FDA Adverse Event
Malfunction
Summary report: N
SUPPORT ARM 177
MDR report key: 3964248
·
Received June 19, 2014
Report
- Report Number
- 8010042-2014-00264
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Report Date
- May 21, 2014
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- IOY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PT INFO WAS INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SUPPORT ARM BROKE. PT INFO IS UNK. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360956 | SUPPORT ARM 177 | IOY | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |