BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI 380

    MDR report key: 7302142 · Received February 28, 2018

    Report

    Report Number
    7302142
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 23, 2018
    Report Date
    February 23, 2018
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO PERFORM AN ECG THE NURSE ACTIVATED THE WIRELESS ACCESS MODULE (WAM), THE DEVICE WOULD NOT CONNECT WITH THE MORTARA ELI380 ECG MACHINE. ANOTHER MACHINE WAS USED WITH THE SAME RESULT (DIFFERENT WAM MODULE ALSO. STAFF CHANGED BATTERIES, ATTEMPTED TO USE THE OTHER WAM MODULES TO SEE IF THEY HAD GOTTEN MIXED UP - IT DID NOT WORK. STAFF CALLED FOR ANOTHER MACHINE AND THE ECG WAS PERFORMED AFTER A SHORT DELAY, NO PATIENT HARM. MANUFACTURER RESPONSE FOR ECG MACHINE, MORTARA (PER SITE REPORTER) DISCUSSED WITH SERVICE TECHNICIAN ISSUE WAS LIKELY RELATED TO ELECTRICAL INTERFERENCE OF SOME TYPE, WHICH PROBABLY RESOLVED BY THE TIME THE OTHER MACHINE, ARRIVED. COULD NOT DUPLICATE THE ISSUE. WE HAVE ORDERED A BACK-UP HARD WIRED TRUNK CABLE TO USE IN CASE OF FUTURE ISSUES WITH THE WIRELESS MODULE TO MINIMIZE DELAY TIME TO DIAGNOSTIC ECG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145546 ELI 380 ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT, INC. ELI380

    Patients

    Seq Age Sex Outcome Treatment
    1 NO