BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMANCE PRO AMBULANCE COT

    MDR report key: 1851302 · Received September 22, 2010

    Report

    Report Number
    1831750-2010-02514
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO FOUND TO BE RELEVANT BY THE MFR WILL BE SUBMITTED IN A F/U MDR.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PLASTIC ON THE INSIDE OF THE WHEEL WHERE THE BEARING MEETS THE WHEEL CRACKED DUE TO A PLASTICS VOID. IT IS CURRENTLY UNK IF THE ALLEGED CONDITION IS A RISK TO SAFETY. A F/U MDR WILL BE SUBMITTED UPON FURTHER INVESTIGATION. NO ADVERSE CONSEQUENCES OR INJURIES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMANCE PRO AMBULANCE COT STRETCHER, WHEELED FPO STRYKER CORP., MEDICAL DIV. 6085 NA

    Patients

    Seq Age Sex Outcome Treatment
    1