FDA Adverse Event
Malfunction
Summary report: N
ZOOM CRITICAL CARE BED
MDR report key: 2021420
·
Received February 16, 2011
Report
- Report Number
- 1831750-2011-01393
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 20, 2011
- Report Date
- January 20, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: SIDE RAIL.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAIL HAS A CRACK IN THE PLASTIC. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZOOM CRITICAL CARE BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 2040 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |