MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-12 for FD1610 manufactured by Getinge Disinfection Ab.
[64579257]
We are aware that for mfr. Ref. No. 9616031-2016-00009 initial report we are past the 30 day deadline for reporting. It was due to the error in processing. This report is being filed under exemption (b)(4) by the manufacturer getinge disinfection ab, ((b)(4)) on behalf of the importer (b)(6), inc. , ((b)(4)). Additional information will be provided upon results of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[64579258]
On (b)(6) 2016 getinge disinfection ab received a customer complaint with the incident report were as stated, the fd1610 device caused electric shock when the technician's hand came into a contact with electrical energy source. The incident occurred during the installation of the new device.
Patient Sequence No: 1, Text Type: D, B5
[67666928]
An investigation was performed on this complaint. Getinge became aware of a complaint where, as stated, our (getinge) service technician received an electrical shock during installation of the new fd1600 device at the customer site. During the installation as per normal installation routine all cables connections shall be checked and secured. It was reported that the technician has discovered disconnected cables on the electro valve for water and when he tried to re-connect it. As per information received the technician forgot to disconnect the device from main electrical supply before starting re-connection cables. The technician received an electric shock which resulted in hospitalization for 24-hours ecg, however after the clinical check the technician went back to work without day delay. When reviewing reportable events for this device we were able to establish that issue with this failure mode is considered as a single, isolated event. Compared to the number of the devices produced (about 6700 devices since 2011) the occurrence rate for reportable complaints with this failure is considered to be very low. The functionality of the device is checked at the manufacturing site during the quality control steps, as per device history file the device was properly functioning when tested at the production floor. However the cables which needed to be re-connected most probably got loose during shipment of the device, therefore it is crucial to check as per description in the technical manual if its connection is proper before the device is ready to use. Technical manual for getinge 1600-series (6001313302, rev. E) includes proper warnings therein an information about risk related to the device use when connected to the electricity supply due to the components being live: "the machine is connected to the electricity supply and some components are live" (page 37, 39, 42, 62, 63). Technical manual also contains information that before any actions are taken on the device the operator shall ensure that the device is disconnected with the main power source: "before starting work, make sure that the machine is disconnected from the electric power supply" (page 49, 53). Based on the findings and looking at outcome of the event we can conclude that proper warnings are included in the technical manual however the technician, although having a proper knowledge hasn't followed it. Based on the collected information we can assume that the device was not used for patient care or cleaning goods at the time of the event, was not up to the manufacturer specification when the event took place and was directly involved in the reportable event. The root cause of the incident is most likely connected with the error during installation of the device as the technician has not followed warnings during installation steps described in the current manuals and has not disconnected the device from the main electrical supply before his activities. When the person would follow the technical manual and disconnect the device from the main supply before his activities, the incident would have been avoided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616031-2016-00009 |
| MDR Report Key | 6245017 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-12 |
| Date of Report | 2017-02-13 |
| Date of Event | 2016-12-07 |
| Report Date | 2016-12-14 |
| Date Reported to Mfgr | 2016-12-14 |
| Date Added to Maude | 2017-01-12 |
| 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 | MS ANN WHEELER |
| Manufacturer Street | 1777 E. HENRIETTA ROAD |
| Manufacturer City | ROCHESTER NY 14623 |
| Manufacturer Country | US |
| Manufacturer Postal | 14623 |
| Manufacturer Phone | 5852725036 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] |
| Manufacturer City | VAXJO, SWEDEN 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 35115 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FD1610 |
| Generic Name | NINJO |
| Product Code | FLH |
| Date Received | 2017-01-12 |
| Model Number | FD1610 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] VAXJO, SWEDEN 35115 SW 35115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-12 |