FDA Adverse Event
Malfunction
Summary report: N
EZ-PRO R4 AMBUL COT
MDR report key: 2191406
·
Received July 28, 2011
Report
- Report Number
- 1831750-2011-07810
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- June 30, 2011
- Report Date
- June 30, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
TROLLEY SUPPORT WELDMENT; TRACK ROLLER ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE COT WILL NOT LOCK IN FULL HEIGHT POSITION DUE TO WORN LOCKING MECHANISM COMPONENTS. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ-PRO R4 AMBUL COT | STRETCHER, WHEELED | INK | STRYKER MEDICAL | 6092 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |