BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITRAK XT

    MDR report key: 15893200 · Received December 1, 2022

    Report

    Report Number
    15893200
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    October 27, 2022
    Report Date
    November 14, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS HSG
    Product Code
    MWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRIED TO DOWNLOAD HOLTER MONITOR (SN# (B)(4). BOTH OCCASIONS MONITOR STATED NO ECG RECORDED. MONITOR PULLED FORM USE TO BE TESTED AND REPAIRED. ORDERING PROVIDER NOTIFIED OF LOSS OF RECORDING AND TO SEE IF THEY WOULD LIKE A REPEAT RECORDING. IF PROVIDER WOULD LIKE A REPEAT THEM WOULD NEED TO WEAR MONITOR AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743241 DIGITRAK XT ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) MWJ PHILIPS MEDICAL SYSTEMS HSG DIGITRAK XT HOLTER RECORDER

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female