FDA Adverse Event
Other
Summary report: N
PRIME ZOOM STRETCHER, 30"LITTER
MDR report key: 2090857
·
Received May 5, 2011
Report
- Report Number
- 1831750-2011-04329
- Event Type
- Other
- Date Received
- May 5, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 6, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- PMA / PMN Number
- K022309
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY CURRENTLY CANNOT DETERMINE WHICH SERIAL NUMBER WAS ALLEGEDLY INVOLVED.
Description of Event or Problem · 1
IT WAS REPORTED A CAREGIVER INJURY OCCURRED REPORTEDLY DUE TO THE PRIME ZOOM STRETCHER BRAKING SYSTEM. PT WAS ON STRETCHER (NO DETAILS ON PT), THE NURSE WENT TO ACTIVATE FOOT PEDAL (HAPPENED BOTH BRAKE/NEUTRAL->STEER AND STEER/NEUTRAL->BRAKE). THE CAREGIVER ALLEGES THE APPROACH ANGLE WAS AWKWARD AND CAUSES HYPEREXTENSION OF KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIME ZOOM STRETCHER, 30"LITTER | WHEELED POWERED STRETCHER | INK | STRYKER MEDICAL | 1125000030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |