FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 3023420
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02583
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 5, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE BED FUNCTIONS WERE LOCKED OUT DUE TO A BUTTON BEING STUCK ON THE HAND PENDANT. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126749 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |