BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER,30"LITTER

    MDR report key: 3081079 · Received April 26, 2013

    Report

    Report Number
    0001831750-2013-03797
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR INITIAL REPORT WAS ISSUED WITHOUT THE PMA/510(K)#. (B)(4). ADDITIONALLY, UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION, IT WAS ALSO DETERMINED THAT THE ZOOM DRIVE WAS INTERMITTENT DUE TO LOOSE ZOOM HANDLES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE IV POLE COULD MOVE IN AN UNINTENDED DIRECTION DUE TO A LOOSE IV POLE SOCKET. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.S

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE IV POLE COULD MOVE IN AN UNINTENDED DIRECTION DUE TO A LOOSE IV POLE SOCKET. 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
    182888 PRIME ZOOM STRETCHER,30"LITTER STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1