BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK PLUS 24 HOUR HOLTER RECORDER

    MDR report key: 1574373 · Received December 22, 2009

    Report

    Report Number
    1218950-2009-02021
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Report Date
    December 1, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MWJ
    PMA / PMN Number
    K993617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY LOADED 3 DIFFERENT PATIENT FILES FROM 3 DIFFERENT RECORDERS WHERE ALL THREE FILES APPEAR TO BE THE SAME. ON THE SAME DAY, THE PHILIPS RESPONSE CENTER HELPED TROUBLESHOOT THE ISSUE WITH THE CUSTOMER. THE CUSTOMER STATED THAT THEY HAD HOLTER APPLICATION SET TO LOAD AN ECG FILE RATHER THAN DOWNLOAD THE ECG FILE FROM THE RECORDER. THIS ACCOUNTS FOR THE CUSTOMER REPORTED PROBLEM. THE PHILIPS RESPONSE CENTER EXPLAINED TO THE CUSTOMER THE CAUSE OF THE PROBLEM. THE CUSTOMER IS NOW AWARE OF THEIR MISTAKE. WE WILL CONSIDER THIS A USER ERROR WHERE THE SAME FILE WAS LOADED MULTIPLE TIMES, AND WHERE THERE WAS CONFUSION ABOUT THE SOURCE OF THE FILES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY LOADED 3 DIFFERENT PATIENT FILES FROM 3 DIFFERENT RECORDERS WHERE ALL THREE FILES APPEAR TO BE THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITRAK PLUS 24 HOUR HOLTER RECORDER MWJ PHILIPS MEDICAL SYSTEMS M3731A

    Patients

    Seq Age Sex Outcome Treatment
    1