MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-03 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[39872592]
On (b)(6) 2016 11:45 am (gmt-5:00) added by (b)(6) ((b)(4)): it was reported that the support arm was found broken. There was no patient involvement reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[53596717]
The investigation of the returned support arm has been finalized. It was reported that the support arm was found broken by our service engineer on another assignment during a service visit at site. Visual inspection shows that there is a clear rupture and in the microscopic investigation the conclusion is that there is no casting defect. This implies that the support arm has been exposed to a mechanical force that's above the designed specification. The support arm has been successfully tested for mechanical strength and is design according to standard. It? S unknown to us under which conditions the reported support arm broke.
Patient Sequence No: 1, Text Type: N, H10
[53596718]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2016-00114 |
| MDR Report Key | 5476244 |
| Date Received | 2016-03-03 |
| Date of Report | 2016-02-16 |
| Date Mfgr Received | 2016-02-16 |
| Date Added to Maude | 2016-03-03 |
| 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 | 2016-03-03 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-03 |