MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-03 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[37781779]
(b)(4). Further information regarding the event has been sought. A supplemental medwatch report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[37781780]
It was reported that the support arm for the ventilator broke. There was no patient involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[42408078]
No parts were returned. Investigation was based on pictures received. According to the pictures provided by the customer, the support arm broke at the joint nearest to the bracket. Prior investigations of similar breakages showed that the cause for the damage can be attributed to the following: cracks / porosity in the casting process, overload, use outside of its specification. Previously performed investigations have lead to a redesign and a change of the manufacturing process in order to obtain a higher mechanical strength of the support arms. This was implemented in production during may 2009. However, despite the attempts to obtain pictures showing the manufacturing date, no additional information has been received. Therefore, the root cause for the breakage cannot be established from this investigation.
Patient Sequence No: 1, Text Type: N, H10
[42408079]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2016-00060 |
| MDR Report Key | 5408318 |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-04 |
| Date Mfgr Received | 2016-01-04 |
| Date Added to Maude | 2016-02-03 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Manufacturer G1 | MAGNUS LINDQVIST |
| Manufacturer Street | MAQUET CRITICAL CARE AB R |
| Manufacturer City | SOLNA |
| Manufacturer Country | SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 177 |
| Generic Name | SUPPORT, ARM |
| Product Code | IOY |
| Date Received | 2016-02-03 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-03 |