BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 3190651 · Received June 26, 2013

    Report

    Report Number
    0001831750-2013-05818
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE REAR WHEEL WAS BROKEN WHICH COULD CAUSE AN UNSTABLE COT. UPON COMPLETION OF THE INVESTIGATION IT WAS FOUND THAT THE WHEEL HUB WAS BROKEN. THE BROKEN WHEEL HUB DID NOT STOP THE COT FROM BEING ABLE TO ROLL AND MANEUVER FOR DEVICE USE. THE BROKEN WHEEL HUB DID NOT AFFECT COT STABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE REAR WHEEL WAS BROKEN WHICH COULD CAUSE AN UNSTABLE COT. 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 REAR WHEEL WAS BROKEN WHICH COULD CAUSE AN UNSTABLE COT. 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
    291566 POWER PRO AMBULANCE COT STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1