BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 8256862 · Received January 17, 2019

    Report

    Report Number
    1226348-2019-10045
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    January 4, 2019
    Report Date
    January 4, 2019
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THERE WAS NO VISIBLE DAMAGE TO THE MILLAR SENSOR, CATHETER, MATERIAL, OR CONNECTOR. THE ICP READING= 531. THE RL READING LOW @8MMHG; TRIED TO POP LID TO ADJUST AND 3 CONNECTOR PINS BROKE OFF DURING EVALUATION. UNABLE TO CONTINUE THE EVALUATION DUE TO THE BROKEN CONNECTOR PINS AND NO FURTHER TESTING WAS POSSIBLE. A REVIEW OF QUALITY RECORDS FOR BOTH THE FINISHED GOOD AND THE COMPONENT FOUND NO DISCREPANCIES. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED ISSUE WAS NOT CONFIRMED AND UNABLE TO DETERMINE THE ROOT CAUSE. NO FURTHER INVESTIGATION OR CORRECTIVE ACTION IS ANTICIPATED.

    Additional Manufacturer Narrative · 0

    UDI (B)(4). THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS RETURNED WITH TWO OTHER SENSORS (MDRS 1226348-2019-10046, 1226348-2019-10047). LABELS FOR THREE LOTS WERE PROVIDED WITH THE THREE MICROSENSORS (LOTS 152001, 186733, 162540); HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE WHICH LOT WAS ASSOCIATED WITH WHICH SENSOR.

    Additional Manufacturer Narrative · 1

    UDI -- (B)(4). IT HAS BEEN REPORTED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION. UPON RECEIPT OF THE DEVICE OR ADDITIONAL RELEVANT INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS AFFILIATE, BEFORE IMPLANTATION, A MICROSENSOR COULD NOT BE ZEROED. IT WAS DISCARDED FOR ANOTHER. A DELAY OF 2 HOURS WAS REPORTED. THE SENSOR WILL BE RETURNED FOR EVALUATION. THIS THE FIRST COMPLAINT OF THREE REGISTERED FOR THIS INCIDENT; THE OTHER TWO ARE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48999 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other