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 |