FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 3021874
·
Received March 26, 2013
Report
- Report Number
- 0001831750-2013-02539
- Event Type
- Malfunction
- Date Received
- March 26, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE BRAKES WOULD NOT ENGAGE DUE TO THE CASTER STEMS BEING DAMAGED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124668 | IN TOUCH EU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |