BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 3908479 · Received June 3, 2014

    Report

    Report Number
    8030229-2014-00002
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    LOANER CNS WAS SENT TO CUSTOMER TO USE DURING THE PERIOD THEY RETURNED THE UNIT FOR REPAIR AND UNTIL THEY RECEIVED THE REPAIRED UNIT. ACTUAL DEVICE BEING RETURNED FOR EVALUATION. IF NEW INFORMATION IS LEARNED, A FOLLOW UP REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324785 CNS-6201 CENTRAL MONITOR SYSTEM MHX NIHON KOHDEN CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1