BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PM9000 MONITOR

    MDR report key: 3091711 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00201
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    September 26, 2012
    Report Date
    April 30, 2013
    Manufacturer
    SHENZHEN BIOMEDICAL ELECTRONICS CO.
    Product Code
    MHX
    PMA / PMN Number
    070791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PM9000 MONITOR FAILED, RESULTING IN A POSSIBLE LOSS OF PRIMARY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187938 PM9000 MONITOR PATIENT MONITOR MHX SHENZHEN BIOMEDICAL ELECTRONICS CO.

    Patients

    Seq Age Sex Outcome Treatment
    1