FDA Adverse Event
Malfunction
Summary report: N
S3 EX - 3005
MDR report key: 3102734
·
Received May 9, 2013
Report
- Report Number
- 0001831750-2013-04193
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 15, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOWLER WAS DRIFTING DUE TO MALFUNCTION FOWLER ACTUATOR. 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 |
|---|---|---|---|---|---|---|---|
| 203682 | S3 EX - 3005 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |