FDA Adverse Event
Malfunction
Summary report: N
ADVANTAGE SERIES 26
MDR report key: 1909606
·
Received November 19, 2010
Report
- Report Number
- 1831750-2010-04018
- Event Type
- Malfunction
- Date Received
- November 19, 2010
- Date of Event
- October 26, 2010
- Report Date
- October 26, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE WELD ON U PUMP BRACKET BROKE AT THE EARS CAUSING BOTH JACK PISTONS TO OVER EXTEND, CAUSING THEM TO LEAK FLUID ON THE FLOOR. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTAGE SERIES 26 | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP., MEDICAL DIVISION | 1001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |