BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORG-9110A

    MDR report key: 4964122 · Received July 29, 2015

    Report

    Report Number
    2080783-2015-00187
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER IS STATING THAT ALL THE RECEIVERS THAT ARE ON THE ORG-9110A MULTI PT RECEIVER ARE SHOWING COMMUNICATION LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492376 ORG-9110A MHX NIHON KOHDEN CORP. ORG-9110A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI