FDA Adverse Event
Malfunction
Summary report: N
S3 SIGNATURE OBS 01/13
MDR report key: 3133196
·
Received May 29, 2013
Report
- Report Number
- 0001831750-2013-04820
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- May 3, 2013
- Report Date
- May 3, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 IN ELEVATED POSITION DUE TO MALFUNCTION 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 |
|---|---|---|---|---|---|---|---|
| 235533 | S3 SIGNATURE OBS 01/13 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |