FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BEDOBS 01/13
MDR report key: 3040669
·
Received April 8, 2013
Report
- Report Number
- 0001831750-2013-02999
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 15, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOTBOARD HAD INTERMITTENT FUNCTION DUE TO PCB MODULE MALFUNCTION. 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 |
|---|---|---|---|---|---|---|---|
| 143620 | SECURE 3 MED/SURG BEDOBS 01/13 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |