BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORG-9100A

    MDR report key: 4143702 · Received August 12, 2014

    Report

    Report Number
    2080783-2014-00033
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRG
    PMA / PMN Number
    K071058
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE ORG-9100A RECEIVER IS DISPLAYING SIGNAL LOSS FOR ALL BEDS. REF MFR # 8030229-2014-00033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480001 ORG-9100A RECEIVER UNIT DRG NIHON KOHDEN CORPORATION ORG-9100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI