FDA Adverse Event
Malfunction
Summary report: N
SM104 M-SERIES W/5TH WHEEL
MDR report key: 2140834
·
Received May 31, 2011
Report
- Report Number
- 1831750-2011-05296
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 3, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY REPORTED THAT JACK DID NOT FUNCTION PROPERLY AND THAT THEY REPLACED THE JACK AND MISSING SCREWS. EVALUATION CODING HAS BEEN PROVIDED BASED UPON THE INFORMATION PROVIDED BY THE USER FACILITY. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INSPECTION OF THE STRETCHER, THE JACK (HYDRAULIC PUMP) OF THE FOOT-SECTION WAS NOT WORKING CORRECTLY AND WAS REPLACED. THERE WERE 2 MISSING SCREWS ON THE BASE OF THE FOOT SECTION JACK. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 M-SERIES W/5TH WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1007 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |