BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI 280

    MDR report key: 6777174 · Received August 9, 2017

    Report

    Report Number
    6777174
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 10, 2017
    Report Date
    July 10, 2017
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE BRACKET THAT HOLDS THE WIRELESS ACQUISITION MODULE(WAM) HAS BROKEN. WE CONTINUE TO SEE THIS QUITE A BIT; IT SHOULD BE REINFORCED. MANUFACTURER RESPONSE FOR EKG CART, ELI280 (PER SITE REPORTER). WE JUST ORDER A NEW PART AND REPAIR IT. BUT EVEN WHILE UNDER WARRANTY THIS BRACKET WAS NOT COVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561034 ELI 280 ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES