BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER, 30" LITTER

    MDR report key: 2221432 · Received August 16, 2011

    Report

    Report Number
    1831750-2011-08706
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULT: CONTROL BOX. THE CUSTOMER RETURNED FOUR CONTROL BOXES REMOVED FROM FOUR OF SIX STRETCHERS THAT THEY REPORTED THE ZOOM DRIVE WAS NOT CHARGING. THE CONTROL BOXES WERE NOT MARKED TO IDENTIFY WHICH STRETCHERS THEY HAD BEEN REMOVED FROM. A F/U REPORT WILL BE SUBMITTED IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ZOOM FEATURE WAS NOT CHARGING ON THIS STRETCHER. DURING ANALYSIS AND TESTING, IT WAS FOUND THAT ONE CONTROL BOX CAUSED THE TEST STRETCHER TO ZOOM WHEN IT WAS PLUGGED IN. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    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