MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-30 for SUPPORT ARM 177 * 6481720 manufactured by Maquet Critical Care Ab.
[924396]
It was reported that the support arm was being adjusted while the ventilator was connected to a pt. The support arm broke and hit the pt. The extent of injury is unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225700-2008-00076 |
| MDR Report Key | 1103603 |
| Date Received | 2008-05-30 |
| Date of Report | 2008-05-22 |
| Date of Event | 2008-05-21 |
| Date Facility Aware | 2008-05-28 |
| Report Date | 2008-05-30 |
| Date Added to Maude | 2008-08-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPPORT ARM 177 |
| Generic Name | IOY |
| Product Code | MOD |
| Date Received | 2008-05-30 |
| Model Number | * |
| Catalog Number | 6481720 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1082877 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | * SOLNA * SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-30 |