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 2014-12-04 for SUPPORT ARM 177 manufactured by Maquet Critical Care Ab.
[18790029]
Imp ref # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18936467]
More info surrounding the event has been sought. A supplemental medwatch will be provided when investigation is finished.
Patient Sequence No: 1, Text Type: N, H10
[63281853]
Our investigation of the returned support arm has been completed. The investigation showed no indications of low friction in the joints. According to the customer, they had tightened the support arm before returning it. The support arm was stretched out and bent several times without friction reduction or a self-lowering at the level of the joints. The support arm joints were dis-mounted to check the friction rings. The friction rings were not worn out or damaged. No fault could be confirmed from inspection of the friction rings or the joints themselves. According to the installation instructions for the support arm the support arm joints shall be adjusted if necessary. Our conclusion is there is no fault with the support arm, the cause for the reported incident was that the support arm joints were not tightened. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010042-2014-00549 |
| MDR Report Key | 4420209 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-12-04 |
| Date Mfgr Received | 2014-11-07 |
| Date Added to Maude | 2015-01-16 |
| 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 | MAGNUS LYNDQVIST |
| Manufacturer City | SOLNA S-17154 |
| Manufacturer Country | SW |
| Manufacturer Postal | S-171 54 |
| Manufacturer Phone | 7307705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 177 |
| Product Code | IOY |
| Date Received | 2014-12-04 |
| 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 | 2014-12-04 |