FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 3151448
·
Received June 7, 2013
Report
- Report Number
- 0001831750-2013-05150
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 14, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE HEAD END LIFT WAS STUCK UP IN ELEVATED POSITION DUE TO MALFUNCTION CABLE HARNESS. 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 |
|---|---|---|---|---|---|---|---|
| 252532 | IN TOUCH EU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |