FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 3203818
·
Received July 3, 2013
Report
- Report Number
- 0001831750-2013-06000
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 10, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE ABLE TO ENGAGE BUT THE FE BRAKES DID NOT HOLD PROPERLY DUE TO THE CASTER STEMS BEING BROKEN. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304617 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |