FDA Adverse Event
Malfunction
Summary report: N
POSITIONPRO WITH PENDANT
MDR report key: 3061404
·
Received April 16, 2013
Report
- Report Number
- 0001831750-2013-03344
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 22, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE POWER CORD WAS MISSING THE GROUND PRONG. 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 |
|---|---|---|---|---|---|---|---|
| 163483 | POSITIONPRO WITH PENDANT | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE | FNM | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |