FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W/ 5TH WHEEL
MDR report key: 2933541
·
Received December 21, 2012
Report
- Report Number
- 1831750-2012-13285
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 29, 2012
- Report Date
- November 29, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
IV POLE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAIL WOULD NOT LATCH IN THE UPRIGHT POSITION, THE BRAKES WERE NOT HOLDING AND THE IV POLE WAS DAMAGED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 MSERIES W/ 5TH WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1007 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |