BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK XT HOLTER RECORDER

    MDR report key: 1490834 · Received October 2, 2009

    Report

    Report Number
    1218950-2009-01440
    Event Type
    Malfunction
    Date Received
    October 2, 2009
    Report Date
    September 2, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MWJ
    PMA / PMN Number
    K993617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A HOLTER RECORDING HAD SHOWN A REPETITIVE WAVEFORM THAT DID NOT LOOK LIKE NOISE. IT ONLY OCCURRED ON THIS RECORDER. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVAL, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HOLTER RECORDING HAD SHOWN A REPETITIVE WAVEFORM THAT DID NOT LOOK LIKE NOISE. IT ONLY OCCURRED ON THIS RECORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITRAK XT HOLTER RECORDER MWJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1