BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSPORT 2

    MDR report key: 2082236 · Received May 5, 2011

    Report

    Report Number
    2082236
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING TRANSFERRED TO ICCU. WHEN THE MONITOR WAS UNPLUGGED TO TRANSPORT WITH THE PATIENT, THE BATTERIES LASTED ABOUT 10 SECONDS BEFORE FAILING. ANOTHER MONITOR WAS OBTAINED IMMEDIATELY AND TRANSPORT CONTINUED WITHOUT INCIDENT. BIOMEDICAL ENGINEERS CHECKED OUT THE MONITOR AND FOUND NO OTHER PROBLEMS. ONCE BATTERIES WERE REPLACED, NO OTHER PROBLEM WAS DETECTED AND THE MONITOR WAS PUT BACK INTO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSPORT 2 MONITOR, PHYSIOLOGICAL MHX MINDRAY DS USA, INC. PASSPORT 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *