FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 3071253
·
Received April 22, 2013
Report
- Report Number
- 0001831750-2013-03623
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- March 25, 2013
- Report Date
- March 27, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE LOAD CELL MALFUNCTION. IT WAS ALSO REPORTED THAT THERE WAS INTERMITTENT POWER TO THE FOOTBOARD AS THE FOOTBOARD WAS DAMAGED. 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 |
|---|---|---|---|---|---|---|---|
| 172666 | IN TOUCH ZU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |