BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX-PRO R-3 AMBULANCE COT

    MDR report key: 3243445 · Received July 23, 2013

    Report

    Report Number
    0001831750-2013-06614
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS FOUND THAT THE ALTHOUGH THE HEIGHT ADJUSTMENT RACKS WERE BENT THEY HAD NO EFFECT ON FUNCTIONALITY OF THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE HEIGHT ADJUSTMENT RACKS WERE BENT WHICH COULD AFFECT COT STABILITY. 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 HEIGHT ADJUSTMENT RACKS WERE BENT WHICH COULD AFFECT COT STABILITY. 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
    343361 MX-PRO R-3 AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1