MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-01-18 for SYSTEM 2000 AP03312-US manufactured by Arjo Hospital Equipment Ab.
[65085679]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[65085680]
Arjohuntleigh has received a customer complaint where it was reported that the tub has tipped over while it was being filled. There was nobody in the room at the time of the incident. Arjohuntleigh technician has visited the facility after incident and found that the left rear bolt on the leg support was broken.
Patient Sequence No: 1, Text Type: D, B5
[69119149]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for system 2000, we have found a low number of similar cases where the tub has tipped over due to leg bolts breakage. There is very low occurrence rate for this kind of events. The incident occurred when the tub was being filled with the water. It was stated that the leg bolt has snapped what lead to the bath's fall. Root cause analysis was performed using ishikawa diagram. It is worth noting that this bath has been under arjo service contract and was checked four times during the year before incident. Before releasing for use by the technician, the bath needs to be in full working condition. What is more, maintenance and repair manual ((b)(4)) gives clear instructions: "screws holding legs shall be checked for torque every year. " "torque 44 nm. Check every year. " therefore, the exact root cause which would be poor maintenance, inaccurate instruction or technician's error can be excluded. The age of the device is significant for this malfunction. Looking at the date of the production of this device, it was manufactured in 2002 and has already passed its operational lifetime as identified in the device labelling 4 years before incident. As stated in the operating and daily maintenance instructions ((b)(4) 2001): "the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instruction, the assembly and installation instructions and the spare part catalogue. " engineering department was consulted in order to understand if the failure could have been visible during the maintenance performed 4 months before the incident. The opinion was that the wear and damage of the bolt is rarely visible when this bolt is exposed to the shear forces. Therefore the technician could have not been able to notice and predict the fracture. As a result, the age of the device is most likely root cause for this complaint. The device was outside of its intended lifetime at the time of the event and the customer will be suggested to take it out of use. This complaint is reported in abundance of caution. The device was not being used for patient care at the time of the incident, it was not to specification most likely due to not following the lifetime indications in the labelling. The device did not play a role in an actual adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2017-00013 |
| MDR Report Key | 6259945 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-01-18 |
| Date of Report | 2017-02-17 |
| Date of Event | 2016-12-21 |
| Date Facility Aware | 2016-12-21 |
| Report Date | 2017-02-17 |
| Date Reported to FDA | 2017-02-17 |
| Date Reported to Mfgr | 2017-02-17 |
| Date Mfgr Received | 2017-01-19 |
| Device Manufacturer Date | 2002-01-21 |
| Date Added to Maude | 2017-01-18 |
| 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. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 98282467 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 2000 |
| Generic Name | BATH, SITZ, POWERED |
| Product Code | ILM |
| Date Received | 2017-01-18 |
| Model Number | AP03312-US |
| Device Availability | Y |
| Device Age | 14 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-18 |