BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENEVIEW MONITOR

    MDR report key: 3091109 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00880
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SHENZHEN BIOMEDICAL ELECTRONICS CO.
    Product Code
    MHX
    PMA / PMN Number
    092449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REPRESENTATIVES REPLACED THE UNIT'S GAS MODULE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE BENEVIEW MONITOR, WHICH MAY HAVE IMPACTED MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187096 BENEVIEW MONITOR PATIENT MONITOR MHX SHENZHEN BIOMEDICAL ELECTRONICS CO.

    Patients

    Seq Age Sex Outcome Treatment
    1