BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V SERIES MONITOR

    MDR report key: 3091323 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00166
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    October 10, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    102004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A PATIENT INCIDENT, THE SPO2 SENSOR HAD COME OFF THE PATIENT AND THE V SERIES MONITOR DID NOT PRODUCE A TECHNICAL ALARM. CUSTOMER, SUBSEQUENTLY, CONFIRMED THAT THE V SERIES HAD NOT BEEN SET UP TO NOTIFY FOR TECHNICAL ALARMS. MDR IS BEING SUBMITTED SINCE THE CUSTOMER REPORTED A PATIENT INCIDENT. CUSTOMER DID NOT ATTRIBUTE INCIDENT TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186442 V SERIES MONITOR PATIENT MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1