BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EV1000 NON-INVASIVE A-LINE

    MDR report key: 8069351 · Received November 14, 2018

    Report

    Report Number
    MW5081203
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 13, 2018
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UNRESPONSIVE MALE PT IN SICU MONITORED WITH NON-INVASIVE A-LINE EV1000. PUMP MOTOR CAUGHT ON FIRE AFTER RN PLUGGED POWER SOURCE INTO ELECTRICAL OUTLET. PT HAD TO BE EVACUATED FROM THE ROOM FOR SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911936 EV1000 NON-INVASIVE A-LINE COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED DXG EDWARDS LIFESCIENCES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention