BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK XT HOLTER RECORDER

    MDR report key: 3004722 · Received February 14, 2013

    Report

    Report Number
    1218950-2013-00539
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 24, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MWJ
    PMA / PMN Number
    K993617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT SMOKE/ODOR COMING FROM A DIGITRAK XT HOLTER RECORDER CAUSED A PT TO HAVE A BURNING SENSATION IN HER EYES. BASED ON THE CUSTOMERS PROBLEM DESCRIPTION THIS WILL BE CONSIDERED A REPORTABLE EVENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SMOKE/ODOR COMING FROM A DIGITRAK XT HOLTER RECORDER CAUSED A PT TO HAVE A BURNING SENSATION IN HER EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65388 DIGITRAK XT HOLTER RECORDER MWJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1