FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 3241352
·
Received July 22, 2013
Report
- Report Number
- 0001831750-2013-06567
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Date of Event
- June 26, 2013
- Report Date
- June 26, 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 VIA REPAIR WORK ORDER THAT THERE WAS A REDUCTION IN BRAKE FORCE DUE TO BROKEN CASTER STEM. 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 |
|---|---|---|---|---|---|---|---|
| 341863 | IN TOUCH EU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |