FDA Adverse Event
Malfunction
Summary report: N
SM104 M-SERIES W/5TH WHEEL
MDR report key: 2140825
·
Received May 31, 2011
Report
- Report Number
- 1831750-2011-05297
- 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 THE CABLES REQUIRED ADJUSTMENT. EVAL CODING HAS BEEN PROVIDED BASED UPON THE INFO PROVIDED BY THE USER FACILITY. SHOULD ADD'L INFO 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 USER FACILITY PERFORMED ADJUSTMENTS TO THE SETTINGS ON CABLES. NO PT 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 |