BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIME ZOOM STRETCHER, 30"LITTER

    MDR report key: 2090856 · Received May 5, 2011

    Report

    Report Number
    1831750-2011-04330
    Event Type
    Other
    Date Received
    May 5, 2011
    Date of Event
    March 15, 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 USER FACILITY CONTACT COULD NOT IDENTIFY A SPECIFIC SERIAL NUMBER RELATED TO THIS CAREGIVERS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO STRYKER MEDICAL THAT A CAREGIVER INJURY OCCURRED DUE TO USE OF THE PRIME ZOOM STRETCHER BRAKING SYSTEM. PT WAS ON STRETCHER (NO DETAILS ON PT), NURSE WENT TO ACTIVATE FOOT PEDAL (HAPPENED BOTH BRAKE/NEUTRAL->STEER AND STEER/NEUTRAL->BRAKE). IT WAS REPORTED THAT THE APPROACH ANGLE WAS "AWKWARD" AND CAUSED HYPEREXTENSION OF KNEE. THE CAREGIVER WAS REPORTED TO COMPLAIN OF KNEE PAIN AND MISSED WORK. NO OTHER INJURY INFO WAS PROVIDED.

    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 45 YR Other