FDA Adverse Event
Malfunction
Summary report: N
POWER LOAD
MDR report key: 3022772
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02563
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- February 26, 2013
- Report Date
- February 26, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE POWER PRO COT CAME DISENGAGED FROM POWER LOAD SYSTEM DUE TO POSSIBLE USER ERROR. IT WAS IDENTIFIED THAT THE POWER LOAD SYSTEM WAS PERFORMING TO SPECIFICATION AND THE ALLEGED ISSUE THE CUSTOMER STATED COULD NOT BE DUPLICATED. THE TECHNICIAN INSERVICED THE CUSTOMER ON PROPER USAGE OF POWER LOAD SYSTEM DUE TO POSSIBLE USER ERROR. 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 |
|---|---|---|---|---|---|---|---|
| 126653 | POWER LOAD | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |