MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-03 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.
[116272122]
The damaged support arm was discarded by the hospital. No parts or pictures were received back for our investigation. No further information was given to clarify where the damage was and how the damage occurred. Therefore no investigation has been possible. We are therefore unable to provide, determine or confirm the cause of the reported damage. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[116272123]
It was reported that the support arm was damaged. There was no patient involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010042-2018-00405 |
| MDR Report Key | 7747400 |
| Date Received | 2018-08-03 |
| Date of Report | 2018-08-03 |
| Date of Event | 2018-07-24 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2008-02-29 |
| Date Added to Maude | 2018-08-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | SUPPORT ARM 177 |
| Generic Name | SUPPORT, ARM |
| Product Code | IOY |
| Date Received | 2018-08-03 |
| Catalog Number | 6481720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-08-03 |