FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 3253556
·
Received July 30, 2013
Report
- Report Number
- 0001831750-2013-06768
- Event Type
- Malfunction
- Date Received
- July 30, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 5, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOTBOARD WAS CAUSING FUSES TO BLOW, RESULTING IN LOSS OF POWER TO THE BED, DUE TO A MALFUNCTIONED MAIN CONTROL BOARD AND POWER ENTRY MODULE. 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 |
|---|---|---|---|---|---|---|---|
| 355892 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |