FDA Adverse Event
Malfunction
Summary report: N
S3 EX - 3005
MDR report key: 3000098
·
Received March 12, 2013
Report
- Report Number
- 0001831750-2013-01947
- Event Type
- Malfunction
- Date Received
- March 12, 2013
- Date of Event
- February 18, 2013
- Report Date
- February 18, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOWLER WAS STUCK IN A ELEVATED POSITION AND WAS NOT ABLE TO LOWER TO IT'S FLAT POSITION DUE TO MALFUNCTION FOWLER ACTUATOR MOTOR. 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 |
|---|---|---|---|---|---|---|---|
| 103829 | S3 EX - 3005 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |