BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEWATCH HOLTER MONITOR

    MDR report key: 6474998 · Received April 10, 2017

    Report

    Report Number
    6474998
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 20, 2017
    Report Date
    April 7, 2017
    Manufacturer
    LIFEWATCH SERVICES INC.
    Product Code
    DXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOLTER MONITOR DONE BY LIFEWATCH AND WHEN OUR PHYSICIAN REVIEWED THE STRIPS, IT WAS CLEARLY NOT THE CORRECT PATIENT. THE REPORT FROM LIFEWATCH DID NOT HAVE ANY ATRIAL FIBRILLATION NOTED WHEN THE PRIMARY REASON FOR THE HOLTER WAS A-FIB. THANKFULLY OUR PHYSICIAN NOTICED THE ERROR AND DID NOT OFFER ANY TREATMENT BASED ON THE WRONG REPORT. LIFEWATCH WAS NOTIFIED AND THEY THEN SENT A "CORRECTED" REPORT THAT HAD THE A-FIB NOTED. BASED ON THIS EVENT, AND THE LACK OF SUPPORT FROM LIFEWATCH WE HAVE CEASED ALL ACTIVITY WITH THIS VENDOR. MANUFACTURER RESPONSE FOR HOLTER MONITOR, LIFEWATCH HOLTER MONITOR (PER SITE REPORTER): THE MANUFACTURER/VENDOR HAS REFUSED TO DISCUSS THESE ONGOING DATA ISSUES WITH US, THEY ARE REQUIRING US TO TALK TO THEIR LEGAL COUNSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257046 LIFEWATCH HOLTER MONITOR TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH DXH LIFEWATCH SERVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR