FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 3023113
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02578
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 4, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THERE WAS INTERMITTENT POWER TO THE FOOTBOARD DUE TO LOOSE FOOTBOARD CONNECTOR PINS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. IT WAS ALSO REPORTED VIA REPAIR WORK ORDER THAT THE POWER CORD HAD DAMAGED SHEATHING. 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 |
|---|---|---|---|---|---|---|---|
| 124998 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |