MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-11-04 for SUPPORT ARM 177 manufactured by Maquet Critical Care Ab.
[20332559]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20493196]
A picture of the broken support arm and the manufacturing date info were received. This info was adequate and therefore the broken support arm was not requested back. The received picture showed that the support arm broke at the joint nearest to the bracket. Info from the hospital stated that the breaking occurred during adjustment and that at the time that it was neither overloaded nor stressed. 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 investigation led to a redesign and a change of the manufacturing process in order to obtain a higher mechanical strength of the support arms. This change was implemented in production during (b)(4) 2009. The broken support arm was manufactured in 2007 before implementation of this change. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010042-2013-00220 |
| MDR Report Key | 3466272 |
| Report Source | 05,06,07 |
| Date Received | 2013-11-04 |
| Date Mfgr Received | 2013-10-10 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2013-11-14 |
| 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 DRIVE |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 177 |
| Product Code | IOY |
| Date Received | 2013-11-04 |
| 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 | 2013-11-04 |