FDA Adverse Event
Malfunction
Summary report: N
SUPPORT ARM 177
MDR report key: 3110543
·
Received April 5, 2013
Report
- Report Number
- 8010042-2013-00051
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- IOY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE SUPPORT ARM HAS BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED AFTER INVESTIGATION. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141888 | SUPPORT ARM 177 | IOY | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |