BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK XT HOLTER RECORDER

    MDR report key: 3004721 · Received February 14, 2013

    Report

    Report Number
    1218950-2013-00538
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 24, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MWJ
    PMA / PMN Number
    K993617
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A PT RETURNING A DIGITRAK XT HOLTER RECORDER STATING THAT SHE WAS BURNED BY THE MONITOR WHILE WEARING IT. SHE ALSO CLAIMED THAT SHE WAS USING HEATED SEATS IN HER CAR AND THAT THE SEAT ALSO SUSTAINED A BURN HOLE. 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 A PT RETURNING A DIGITRAK XT HOLTER RECORDER STATING THAT SHE WAS BURNED BY THE MONITOR WHILE WEARING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64578 DIGITRAK XT HOLTER RECORDER MWJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1