BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX-PRO R-3 AMBULANCE COT

    MDR report key: 3120827 · Received May 20, 2013

    Report

    Report Number
    0001831750-2013-04558
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FOUND DURING INVESTIGATION THAT THE FOOT END CASTER HORN ASSEMBLY WAS MISSING WHICH WILL AFFECT COT STABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE OUTER BASE TUBES ARE BROKEN AT THE WELD AND THAT THE BASE CANNOT BE RETRACTED. 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 OUTER BASE TUBES ARE BROKEN AT THE WELD AND THAT THE BASE CANNOT BE RETRACTED. 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
    221939 MX-PRO R-3 AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1