FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 2991501
·
Received March 6, 2013
Report
- Report Number
- 0001831750-2013-01811
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 11, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES WERE NOT DISENGAGING DUE TO BROKEN CASTER STEMS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95974 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |