BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-6201

    MDR report key: 4173578 · Received September 10, 2014

    Report

    Report Number
    8030229-2014-00050
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RETURNED AND IS UNDERGOING FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559819 CNS-6201 CENTRAL MONITOR SYSTEM MHX

    Patients

    Seq Age Sex Outcome Treatment
    1