FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BEDOBS 01/13
MDR report key: 3122589
·
Received May 21, 2013
Report
- Report Number
- 0001831750-2013-04587
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 25, 2013
- Report Date
- April 25, 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 FOOT END OF BED WOULD NOT RAISE OR LOWER AND STUCK IN PARTIALLY ELEVATED POSITION DUE TO MALFUNCTIONED COUPLER. 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 |
|---|---|---|---|---|---|---|---|
| 223716 | SECURE 3 MED/SURG BEDOBS 01/13 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |