FDA Adverse Event
Malfunction
Summary report: N
EZ-PRO R4 AMBUL COT
MDR report key: 2113639
·
Received May 24, 2011
Report
- Report Number
- 1831750-2011-04986
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 27, 2011
- Report Date
- April 27, 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
CASTER HORN.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BASE TUBES WERE CRACKED AND THE CASTERS WERE UNABLE TO PIVOT. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE ARE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ-PRO R4 AMBUL COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL | 6092 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |