BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD 545 PCA INFUSION PUMP

    MDR report key: 8394010 · Received March 6, 2019

    Report

    Report Number
    8394010
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    January 29, 2019
    Report Date
    February 12, 2019
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ABOUT 5 MINUTES PRIOR TO OBSERVING THE DEVICE SHUTDOWN, THE PUMP EMITTED AN UNFAMILIAR BEEPING AND THE GREEN LIGHT WAS BLINKING. THE SCREEN READ "NEAR END". THE RESPIRATORY THERAPIST CLEARED THE ERROR; THEN, THE DEVICE SHUT DOWN SHORTLY AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189449 BODYGUARD 545 PCA INFUSION PUMP PUMP, INFUSION, PCA MEA CAESAREA MEDICAL ELECTRONICS LTD. 545

    Patients

    Seq Age Sex Outcome Treatment
    1