FDA Adverse Event
Malfunction
Summary report: N
PRIME ZOOM STRETCHER, ELECTRIC
MDR report key: 3160131
·
Received June 10, 2013
Report
- Report Number
- 0001831750-2013-05266
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 14, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM HAS INTERMITTENT POWER DUE TO MALFUNCTIONED BATTERIES. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260173 | PRIME ZOOM STRETCHER, ELECTRIC | STRETCHER, WHEELED, POWERED | INK | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |