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 |