BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYMED HOLTER SOFTWARE

    MDR report key: 1181598 · Received September 26, 2008

    Report

    Report Number
    1218950-2008-00524
    Event Type
    Injury
    Date Received
    September 26, 2008
    Report Date
    August 27, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE PATIENT MENTIONED THAT THE HOLTER BATTERY CASE AND ELECTRODES BURNT HER TO THE POINT OF BLEEDING. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION ABOUT THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT MENTIONED THAT THE HOLTER BATTERY CASE AND ELECTRODES BURNT HER TO THE POINT OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYMED HOLTER SOFTWARE ELECTROCARDIOGRAPH, AMBULATORY, WITH DPS PHILIPS MEDICAL SYSTEMS 860292

    Patients

    Seq Age Sex Outcome Treatment
    1