BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 1910167 · Received November 1, 2010

    Report

    Report Number
    1226348-2010-00352
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 30, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC, MEDOS S.A.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE MACHINE DISPLAYED THAT IT COULD NOT BE "ZEROED." THE DEFECTIVE PRODUCT CAUSED A DELAY DURING THE OPERATION BECAUSE ANOTHER ONE HAD TO BE BROUGHT IN. CUSTOMER DID NOT KEEP OF A RECORD FOR THE DELAY TIME, HOWEVER AS A CONSERVATIVE MEASURE THE EVENT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC, MEDOS S.A. NA CLJCRL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK