FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZX
MDR report key: 2021502
·
Received February 16, 2011
Report
- Report Number
- 1831750-2011-01483
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- December 23, 2010
- Report Date
- December 23, 2010
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED EXIT HAS NO AUDIBLE ALARM WHEN ACTIVATED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZX | AC HOSPITAL BED | FNL | STRYKER MEDICAL | 2140 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |