FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 3013560
·
Received March 20, 2013
Report
- Report Number
- 0001831750-2013-02244
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 19, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT HOLDING DUE TO THE CASTER STEMS BEING BROKEN. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115451 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |