BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER,30"LITTER

    MDR report key: 3112392 · Received May 14, 2013

    Report

    Report Number
    0001831750-2013-04376
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR INITIAL WAS ISSUED WITHOUT THE PMA/510(K)#. THIS HAS BEEN INCLUDED IN THIS SUPPLEMENTAL REPORT. ADDITIONALLY, UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS DETERMINED THAT THE ZOOM DRIVE WAS INTERMITTENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ZOOM DRIVE ACCELERATES TOO QUICKLY. 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 ZOOM DRIVE ACCELERATES TOO QUICKLY. 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
    212363 PRIME ZOOM STRETCHER,30"LITTER STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1