BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSENSOR

    MDR report key: 5904607 · Received August 25, 2016

    Report

    Report Number
    1226348-2016-10606
    Event Type
    Malfunction
    Date Received
    August 25, 2016
    Date of Event
    August 10, 2016
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PART NUMBER, UDI UNAVAILABLE. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    JJM REP RECEIVED A PHONE CALL TO ASSESS A MICRO SENSOR THAT WAS NOT ALLOWING THE ICP EXPRESS TO SET A ZERO READING. MICRO SENSOR HAD BEEN IMPLANTED IN THEATRE AND HAD BEEN FUNCTIONING CORRECTLY, BUT WHEN REATTACHED TO ICP UNIT IN ICU, WOULD NOT ALLOW A ZERO READING TO BE PERFORMED AND INSERT 3 DIGIT CODE. ICP EXPRESS UNIT DISPLAYING COMMENT "UNABLE TO ZERO REFERENCE... TRY AGAIN. TWO DIFFERENT ICP EXPRESS UNITS USED, TWO DIFFERENT GREY CABLES USED, ALL TO NO EFFECT. ICP READING COULD ONLY BE PERFORMED THROUGH ALREADY INSERTED EVD. MICRO SENSOR NOT FUNCTIONING. MICRO SENSOR NOT WORKING, EVD ALREADY IMPLANTED ALLOWED BACK UP PRESSURE READING. NO ADVERSE OUTCOME TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557138 MICROSENSOR DEVICE, INTRACRANIAL PRESSURE MONITORING GWM

    Patients

    Seq Age Sex Outcome Treatment
    1