FDA Adverse Event
Malfunction
Summary report: N
MX-PRO IT COT
MDR report key: 2092403
·
Received May 3, 2011
Report
- Report Number
- 1831750-2011-04224
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE COT WAS DROPPED OFF THE BACK OF THE AMBULANCE DURING EMPTY UNLOADING. THE WEIGHT OF THE INCUBATOR, ACCESSORIES AND SLED CAUSED DAMAGE. CROSS BAR DAMAGE WAS CAUSED BY NOT LIFTING FAR ENOUGH FOR PINS TO CLEAR LATCH BARS BEFORE OPERATING RELEASE HANDLE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT END SKIN IS BROKEN. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MX-PRO IT COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL | 6081 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |