FDA Adverse Event
Malfunction
Summary report: N
EYE SURGERY STRETCHER OBS 3/07
MDR report key: 3092292
·
Received May 3, 2013
Report
- Report Number
- 0001831750-2013-04066
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- March 28, 2013
- Report Date
- March 28, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE JACK COULD NOT PUMP UP DUE TO A MISSING RETURN SPRING. HOWEVER, THE JACK COULD BE PUMPED UP BY MANUALLY RESETTING THE PUMP PEDAL, IF NECESSARY. 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 |
|---|---|---|---|---|---|---|---|
| 195098 | EYE SURGERY STRETCHER OBS 3/07 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 1069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |