FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 2984186
·
Received February 28, 2013
Report
- Report Number
- 0001831750-2013-01594
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 15, 2013
- Report Date
- January 15, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BED HAD LOSS OF ALL MOTOR FUNCTIONS DUE TO THE CPU BOARD. 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 |
|---|---|---|---|---|---|---|---|
| 87335 | IN TOUCH EU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |