MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-05-16 for SUPPORT ARM 177 manufactured by Maquet Critical Care Ab.
[18249477]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18324029]
Only part of the support arm was returned. The part that was returned was the lowest pivot arm and it was broken in the articulating join. Visual inspection showed that the broken section was porous. The returned part did not include date stamp but according to the customer it was purchased in 2005. The customer stated that support arms are not overloaded or used to pull ventilators during transport but stated that sometimes the support arms "touch" the large stands. This can imply that impacts occur. The support arm is a casting and it most probably developed a crack at an earlier occasion either by overloading or impact and this led to the reported breaking. Previous investigations led to a redesign and a change of mfg process in order to obtain a higher mechanical strength of the support arms. This change was implemented in production during (b)(6) 2009. The support arm in this report was manufactured before implementation of this change. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010042-2013-00076 |
| MDR Report Key | 3126589 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-05-16 |
| Date Mfgr Received | 2013-04-18 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2013-05-24 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DR |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET CRITICAL CARE AB |
| Manufacturer City | SOLNA S-17154 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | S-17154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 177 |
| Product Code | IOY |
| Date Received | 2013-05-16 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | 2 ROENTGENVAGEN SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-16 |