FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 2910143
·
Received December 19, 2012
Report
- Report Number
- 1831750-2012-13024
- Event Type
- Malfunction
- Date Received
- December 19, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 20, 2012
- Manufacturer
- FLEXTRONICS EMS CANADA
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE CASTER SEAMS FAILED AND THE BRAKES ON FOOT AND HEAD WERE NOT WORKING PROPERLY. ALSO STEERING WAS NOT WORKING PROPERLY. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH EU | A/C HOSPITAL BED | FNL | FLEXTRONICS EMS CANADA | 2131 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |