BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAD CONNECTOR CABLE

    MDR report key: 1770134 · Received July 21, 2010

    Report

    Report Number
    1218950-2010-01188
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE PACER TEST. THE CUSTOMER LOCALIZED THE ISSUE TO A FAILED PADS CABLE. THE CUSTOMER WAS SENT A REPLACEMENT CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE PACER TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAD CONNECTOR CABLE MKJ PHILIPS MEDICAL SYSTEMS M3508A 04/09

    Patients

    Seq Age Sex Outcome Treatment
    1