BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VSM

    MDR report key: 1113326 · Received August 12, 2008

    Report

    Report Number
    3023750-2008-00192
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K031740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - INSUFFICIENT EVIDENCE OR INFORMATION LEADING TO CAUSE CANNOT BE DETERMINED. EVALUATION SUMMARY: THE DEVICE IS AN AC TO DC POWER CONVERTER THAT HAS NOT BEEN RETURNED BUT WAS INVESTIGATED USING PHOTOGRAPHIC IMAGES. THE IMAGES REVEALED THAT THE OUTER ORANGE INSULATION ON THE AC POWER CORD (RESULT) WAS STRETCHED AND SEPARATED, REVEALING THE INTERNALLY INSULATED WIRES WHICH WERE UNAFFECTED BY THE STRETCHING EVENT. EVALUATING THE PICTURES TAKEN OF THE AFFECTED MATERIAL CONFIRMED THE STRETCHED AND SEPARATED OUTER INSULATION SHEATH OF THE AC POWER CORD. THE CAUSE OF THE STRETCHING ACTION TO ALLOW THE OUTER INSULATION TO BREAK CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER RAISED SAFETY CONCERNS RELATING TO THE OUTER ORANGE INSULATION ON THE 240V AC POWER CORD. THE OUTER ORANGE INSULATION STRETCHED AND SEPARATED SEVERAL INCHES BELOW THE IEC CONNECTOR ALLOWING THE INDIVIDUAL INSULATED AC CONDUCTOR WIRES TO BE VIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSM DQA WELCH ALLYN PROTOCOL, INC. VSM300

    Patients

    Seq Age Sex Outcome Treatment
    1