BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSYNC

    MDR report key: 236745 · Received April 2, 1999

    Report

    Report Number
    MW1017017
    Event Type
    Malfunction
    Date Received
    April 2, 1999
    Date of Event
    March 15, 1999
    Report Date
    April 2, 1999
    Manufacturer
    ACCUSYNC MEDICAL RESEARCH CORP.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCUSYNC ECG DEVICE GENERATES R-WAVE AND TRIGGER WITHOUT A PT ATTACHED. DR COMPLAINED THAT SEVERAL PTS WERE ACQUIRED INCORRECTLY WHEN LEADS HAD DISCONNECTED FROM ACCUSYNC DEVICE. THE DEVICE DOES NOT GIVE ANY INDICATION THAT THE LEADS HAVE BEEN DISCONNECTED. PTS' RESULTS WERE INCONCLUSIVE AND THE PT STUDIES HAD TO BE REPEATED. APPROX AGE OF DEVICE 1 WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSYNC ECG GATING DEVICE DRT ACCUSYNC MEDICAL RESEARCH CORP. 5220335 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other