FDA Adverse Event
Malfunction
Summary report: N
SUPPORT ARM 177
MDR report key: 1103603
·
Received May 30, 2008
Report
- Report Number
- 1225700-2008-00076
- Event Type
- Malfunction
- Date Received
- May 30, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 22, 2008
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- MOD
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPPORT ARM 177 | IOY | MOD | MAQUET CRITICAL CARE AB | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |