FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 2021467
·
Received February 16, 2011
Report
- Report Number
- 1831750-2011-01480
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT RIGHT SIDERAIL WAS BROKEN OFF THE BED. INVESTIGATION DETERMINED THERE WERE EXPOSED SHARP EDGES AND THAT THE SIDERAIL DID NOT LOCK IN THE HIGHEST POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZU | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | 2141 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |