FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHL
MDR report key: 1874952
·
Received October 13, 2010
Report
- Report Number
- 1831750-2010-02820
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- July 22, 2010
- Report Date
- September 16, 2010
- Manufacturer
- STRYKER CORP. MEDICAL DIVISION
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE IDENTITY OF THE USER FACILITY, CONTACT NAME, PHONE NUMBER AND DEVICE SERIAL NUMBER WERE NOT PROVIDED, THEREFORE EVALUATION CANNOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED VIA A VOLUNTARY MEDWATCH REPORT FROM THE USER FACILITY "STRYKER 1005 STRETCHER BEING USED IN TRAINING FOR NEW LIFT SYSTEM SLID AWAY FROM BED CAUSING EMPLOYEE TO FALL TO THE FLOOR. THE FOOT LOCK WAS ENGAGED. UPON FURTHER INSPECTION, IT WAS NOTED THE FOOT LOCK IS NOT CONSISTENT IN LOCKING EVERY TIME UNLESS THE PEDAL IS PUSHED VERY HARD OR THE LOCK ON THE HEAD END IS UTILIZED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 MSERIES W5TH WHL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP. MEDICAL DIVISION | 1005 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |