FDA Adverse Event
Malfunction
Summary report: N
PRIME ZOOM STRETCHER, ELECTRIC
MDR report key: 2990858
·
Received March 6, 2013
Report
- Report Number
- 0001831750-2013-01769
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 11, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- INK
- PMA / PMN Number
- K022309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE STRETCHER HAD INTERMITTENT ZOOM DUE TO A MALFUNCTIONED CSI BOX. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE STRETCHER HAD INTERMITTENT ZOOM DUE TO A MALFUNCTIONED CSI BOX. 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 |
|---|---|---|---|---|---|---|---|
| 95114 | PRIME ZOOM STRETCHER, ELECTRIC | STRETCHER, WHEELED, POWERED | INK | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |