BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAD CONNECTOR CABLE

    MDR report key: 2222425 · Received July 14, 2011

    Report

    Report Number
    1218950-2011-02002
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    March 8, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILED OPERATIONAL CHECK. THE CUSTOMER VERIFIED THAT THE CABLE FAILED ON SEVERAL DIFFERENT MONITORS ON DIFFERENT DAYS. THE CABLE WAS REPLACED TO RESOLVE THE ISSUE. THE CABLE WAS NOT AVAILABLE FOR EVAL. THERE WAS NO REPORTED PT INVOLVEMENT. WE WILL CONSIDER THIS A MALFUNCTION OF THE PADS CABLE WHICH COULD PREVENT THE DELIVERY OF THERAPY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILED OPERATIONAL CHECK. THE CUSTOMER VERIFIED THAT THE CABLE FAILED ON SEVERAL DIFFERENT MONITORS ON DIFFERENT DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAD CONNECTOR CABLE MKJ PHILIPS HEALTHCARE - ANDOVER M3508A 04/2009

    Patients

    Seq Age Sex Outcome Treatment
    1