FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 3013305
·
Received March 20, 2013
Report
- Report Number
- 0001831750-2013-02237
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 25, 2013
- Report Date
- February 25, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BRAKES ARE NOT ENGAGING DUE TO BROKEN CASTER STEMS. 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 |
|---|---|---|---|---|---|---|---|
| 115564 | IN TOUCH EU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |