BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX-PRO R-3 AMBULANCE COT

    MDR report key: 3162273 · Received June 11, 2013

    Report

    Report Number
    0001831750-2013-05272
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE COT WAS DIFFICULT TO RAISE. UPON COMPLETION OF THE INVESTIGATION IT WAS FOUND THAT THE HEIGHT ADJUSTMENT RACKS WOULD NOT RAISE FULLY DUE TO BINDING AS A RESULT OF BEING BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE UNIT WAS DIFFICULT TO RAISE AND LOWER DUE TO BENT HEIGHT ADJUSTMENT RACKS. 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 UNIT WAS DIFFICULT TO RAISE AND LOWER DUE TO BENT HEIGHT ADJUSTMENT RACKS. 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
    262258 MX-PRO R-3 AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1