BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHS MICROSENSOR BASIC KIT

    MDR report key: 8264526 · Received January 21, 2019

    Report

    Report Number
    1226348-2019-10047
    Event Type
    Injury
    Date Received
    January 21, 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

    Narratives

    Additional Manufacturer Narrative · 0

    UDI (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. CATHETER MATERIAL HAS A SLIGHT KINK 31CM FROM THE CONNECTOR WITH NO OTHER VISIBLE DAMAGE. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. BASED ON THE EVALUATION, THE COMPLAINT HAS NOT BEEN CONFIRMED. NO FURTHER INVESTIGATION OR CORRECTIVE ACTION IS ANTICIPATED. A REVIEW OF QUALITY RECORDS FOR BOTH THE FINISHED GOOD AND THE COMPONENT FOUND NO DISCREPANCIES.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UDI (B)(4). THE DEVICE WAS RETURNED WITH TWO OTHER SENSORS (MDRS 1226348-2019-10045, 1226348-2019-10046). 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

    (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 AND AFTER BEING ZEROED, A MICROSENSOR CAUSED AN ERROR MESSAGE TO BE DISPLAYED ON THE MONITOR. IT WAS DISCARDED; IT IS NOT KNOWN WHAT ACTION WAS TAKEN TO MONITOR THE PATIENT'S ICP. A DELAY OF 2 HOURS WAS REPORTED. THE SENSOR WILL BE RETURNED FOR EVALUATION. THIS IS THE THIRD COMPLAINT OF THREE REGISTERED FOR THIS INCIDENT; THE OTHER TWO ARE (B)(4) AND (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57973 ROHS MICROSENSOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other