BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIME ZOOM STRETCHER,30"LITTER

    MDR report key: 3120372 · Received May 20, 2013

    Report

    Report Number
    0001831750-2013-04538
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    INK
    PMA / PMN Number
    K022309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 ALSO DETERMINED THAT THE SCALE WAS INACCURATE AS A RESULT OF THE DAMAGE, AS WELL AS HAVING SHARP EDGES REPORTEDLY BEING EXPOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SCALE DISPLAY WAS BROKEN RESULTING IN EXPOSED SHARP EDGES. 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 SCALE DISPLAY WAS BROKEN RESULTING IN EXPOSED SHARP EDGES. 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
    221822 PRIME ZOOM STRETCHER,30"LITTER STRETCHER, WHEELED, POWERED INK STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1