BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PRO AMBULANCE COT

    MDR report key: 1830076 · Received September 7, 2010

    Report

    Report Number
    1831750-2010-02130
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOUND TO BE RELEVANT BY THE MANUFACTURER WILL BE INCLUDED IN THE INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED IN A SERVICE REPORT THAT THE HEAD RIGHT CORNER OF THE BREAK AWAY HEAD SECTION WAS CRACKED WHERE THE WHEEL MOUNTS ON THE AMBULANCE COT. NO ADVERSE CONSEQUENCES OR INJURIES HAVE BEEN REPORTED. THE SEVERITY OF THE ALLEGED CRACK ON THE HEAD SECTION WHERE THE LOAD WHEEL MOUNTS IS CURRENTLY KNOWN AND AWAITING FURTHER INVESTIGATION. ADDITIONAL INFORMATION FOUND TO BE RELEVANT BY THE MANUFACTURER WILL BE INCLUDED IN THE INVESTIGATION, AND A FOLLOW-UP MDR WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PRO AMBULANCE COT STRETCHER WHEELED FPO STRYKER CORP., MEDICAL DIV. 6500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK