BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION / V SERIES MONITOR

    MDR report key: 3102670 · Received May 1, 2013

    Report

    Report Number
    2221819-2013-00762
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC
    Product Code
    MHX
    PMA / PMN Number
    031760/1020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPS EVALUATED THE PANORAMA CENTRAL STATION AND V SERIES MONITOR AND BOTH RESPONDED WITH LETHAL ALARMS IN TESTING. RETURNED TO SERVICE AFTER TESTING TO FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED NO LETHAL ALARMS AT THE PANORAMA CENTRAL STATION OR THE V SERIES MONITOR WHEN A RUN OF VTACH WAS WITNESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190809 PANORAMA CENTRAL STATION / V SERIES MONITOR CENTRAL STATION/ PATIENT MONITOR MHX MINDRAY DS USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1