FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BEDOBS 01/13
MDR report key: 3182018
·
Received June 21, 2013
Report
- Report Number
- 0001831750-2013-05636
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 28, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 MOTOR ASSEMBLY. 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 |
|---|---|---|---|---|---|---|---|
| 283322 | SECURE 3 MED/SURG BEDOBS 01/13 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |