FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 3211584
·
Received July 8, 2013
Report
- Report Number
- 0001831750-2013-06147
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- June 12, 2013
- Report Date
- June 13, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE NURSE CALL SYSTEM DID NOT FUNCTION DUE TO HEAD WALL INTERFACE BOARD MALFUNCTION. 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 |
|---|---|---|---|---|---|---|---|
| 311639 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |