FDA Adverse Event
Malfunction
Summary report: N
EYE SURGERY STRETCHER
MDR report key: 3180026
·
Received June 20, 2013
Report
- Report Number
- 0001831750-2013-05597
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 23, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE HEAD END JACK WAS DRIFTING DUE TO MALFUNCTIONED JACK ASSEMBLY. 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 |
|---|---|---|---|---|---|---|---|
| 280490 | EYE SURGERY STRETCHER | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |