MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-10-02 for ELEKTA NEUROMAG WITH MAXFILTER NM25000N manufactured by Elekta Oy.
[27296262]
The main device (elekta neuromag triux) is a magnetoencephalograph, the magnetic counter part of eeg. The device measures magnetic field, which is very weak, and can only be measured with super conducting sensors. Thus the sensors are kept in liquid helium. The part involved in the incident was the internal helium recycler (ihr), which is an optional non-medical device but will become a part of medical device when installed. The purpose of the ihr is to reduce the helium consumption. The ihr is an option for the main system. There are only two installations world wide, both in (b)(4). The manufacturer's preliminary investigation found that the incident happened when both the elekta oy service engineer and product development engineers were on site to perform after-installation service to the pilot device. In the future, only elekta service engineers are allowed to service ihr, thus hospital engineers will never service the ihr. At present, there are only four service engineers trained to work on ihr, all elekta oy employees. When servicing the compressor assembly in the cabinet, the engineer followed the service instructions for changing the gas collection pump. The power cable of the cabinet is connected to the din rail of the compressor assembly from which it continues to ups. The ups powers the cabinet. Outputs of the ups were detached according to the instruction, but the main power cable was still in contact with mains power and thus also the din rail of the compressor assembly was having the mains voltage. The electric shock source was the main power cable, which was connected to the din rail. The main power cable could have been depowered by switching the power off from the main switch. In the beginning of the service manual there is a general instruction to always depower the system from the main switch, but this instruction is not repeated separately for each task. Thus the ultimate root cause for the incident was human error. As there were both service and product development participating, there might have been some confusion regarding who is ultimately responsible for ensuring that the mains power is powered off. Power supply of the device is fed through a medical safety isolation transformer. In this case the medical safety isolation transformer prevented worse outcome, as intended. Refresher training on electrical safety has been given to elekta oy service engineers. All elekta oy employees who work on electrical installations will attend additional electrical safety training. An investigation has been initiated to assess the need for further corrective actions, details of which will be included in the final report.
Patient Sequence No: 1, Text Type: N, H10
[27296263]
An elekta service engineer was performing a service operation of the helium recycler cabinet of the internal helium recycler (ihr). During the service, he got an electric shock in his arm due to which the arm was temporarily numb but there was no permanent injury. The engineer visited the doctor and had a health check the following day. Everything was ok. When servicing the compressor assembly in the cabinet, the engineer followed the service instructions for changing the gas collection pump. The power cable of the cabinet is connected to din rail of the compressor assembly from which it continues to the ups (uninterruptible power supply). The ups powers the cabinet. Outputs of the ups were detached according to the instruction, but the main power cable was still in contact with mains power and thus also the din rail of the compressor assembly was having the mains voltage. The electric shock source was the main power cable, which was connected to the din rail. The main power cable could have been depowered by switching the power off from the main switch.
Patient Sequence No: 1, Text Type: D, B5
[33784215]
The manufacturer's investigation concluded that the incident happened when both the elekta oy service engineer and product development engineers were on site to perform an after-installation service to the pilot internal helium recycler (ihr). When servicing the compressor assembly in the cabinet, the engineer followed the service instructions for changing the gas collection pump. The compressor assembly resembles mechanically the gas collection pump assembly, but differs in respect of powering arrangement: the main power cable of the cabinet is connected to the din rail of the compressor assembly from which it continues to ups. The ups powers the cabinet. Outputs of the ups were detached according to the instruction, but the main power cable was still in contact with mains power and thus also the din rail of the compressor assembly was having the mains voltage. The electric shock source was the main power cable. The service engineer detached the main power cable from the din rail, and the bare end of the cable touched his arm. The main power cable could have been depowered by switching the power off from the main switch. Power supply of the device is fed through a medical safety isolation transformer. In this case the medical safety isolation transformer prevented worse outcome, as intended. Only trained elekta service engineers are allowed to work on the ihr. In the beginning of the service manual there is a general instruction to always depower the system from the main switch, but this instruction is not repeated separately for each task. As there were both service and product development participating to the service, there might have been some confusion regarding who is ultimately responsible for ensuring that the mains power is powered off. The ultimate root cause for the incident was human error. Elekta oy has opened (b)(4) to handle the corrective and preventive actions. As the actions included an update in the field, elekta oy has reported the field safety corrective action under reference number fca-oy-0001 on 30th october 2015. The corrective and preventive actions are listed as follows:- - refresher training on electrical safety has been given to elekta oy service engineers. Also, all elekta oy employees who work on electrical installations have attended additional external electrical safety training. - elekta oy will create a procedure for electrical work. All applicable employees will be trained. Estimated completion by end of january 2016. - the design of all new ihrs has been changed, so that the main power cable is re-routed not go through the cover of the compressor assembly. In addition, a warning sticker has been added to the design to remind the service engineer to always depower the mains power before servicing. This design change will be implemented to the devices on the field through the fca-oy-0001. Note that the warning sticker has already been attached to the devices in the field. - the ihr service manual will be updated so that the instruction to depower the installation is stated in the beginning of each task. Estimated completion by end of january 2016. - elekta oy manual validation instruction has been updated to include a review of an electrical safety expert for service and installation manuals. Estimated release by end of january 2016. The design change will be implemented by the end of april 2016. The manufacturer is not aware of similar incidents with this type of medical device with a similar root cause. The device has not been distributed in the us.
Patient Sequence No: 1, Text Type: N, H10
[33784216]
An elekta service engineer was performing a service operation of the helium recycler cabinet of the internal helium recycler (ihr). During the service, he got an electric shock in his arm due to which the arm was temporarily numb but there was no permanent injury. The engineer visited the doctor and had a health check the following day. Everything was ok. When servicing the compressor assembly in the cabinet, the engineer followed the service instructions for changing the gas collection pump. The power cable of the cabinet is connected to din rail of the compressor assembly from which it continues to the ups (uninterruptible power supply). The ups powers the cabinet. Outputs of the ups were detached according to the instruction, but the main power cable was still in contact with mains power and thus also the din rail of the compressor assembly was having the mains voltage. The electric shock source was the main power cable, which was connected to the din rail. The main power cable could have been depowered by switching the power off from the main switch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680891-2015-00001 |
| MDR Report Key | 5123040 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-02 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-09-09 |
| Date Mfgr Received | 2015-09-09 |
| Device Manufacturer Date | 2015-06-08 |
| Date Added to Maude | 2015-10-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GPMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA OY |
| Manufacturer Street | SILTASAARENKATU 18-20A |
| Manufacturer City | HELSINKI, 00530 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 00530 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEKTA NEUROMAG WITH MAXFILTER |
| Generic Name | SOURCE LOCALIZATION SOFTWARE FOR ELECTROENCEPHALOGRAPH OR MAGNETOENCEPHALOGRAPH |
| Product Code | OLX |
| Date Received | 2015-10-02 |
| Model Number | NM25000N |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA OY |
| Manufacturer Address | SILTASAARENKATU 18-20A HELSINKI, 00530 FI 00530 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-02 |