BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVENT-P

    MDR report key: 8484204 · Received April 4, 2019

    Report

    Report Number
    3006942548-2019-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 13, 2019
    Report Date
    March 13, 2019
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    PMA / PMN Number
    K103206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER STATEMENT: FOR EVALUATION OF THE MALFUNCTION DHR DOCUMENTS WERE REVIEWED. THEY DEMONSTRATE THAT THE CATHETER NEUROVENT-P (SN (B)(4)) MET SPECIFICATION DURING MANUFACTURING. FINAL INSPECTION OF THE FINISHED CATHETER WAS PASSED. THIS DEMONSTRATES THAT THE CATHETER HAS BEEN MANUFACTURED AND SOLD IN CONFORMANCE TO RELEVANT SPECIFICATIONS. FURTHERMORE RETURNED CATHETER WAS INVESTIGATED. THIS INVESTIGATION DEMONSTRATES THAT ONE WIRE IS TORN APART FROM THE SOLDERING PADS ON THE PCB. BASED ON KNOWLEDGE THAT THE FINAL INSPECTION OF THE FINISHED CATHETER WAS PASSED, THAT THE CATHETER WAS DELIVERED WITH PROPER FUNCTIONALITY AND IN CONSIDERATION OF THE RESULTS OF PERFORMED INVESTIGATION OF RETURNED CATHETER, THE TEAR-OFF OF THE WIRE IS CAUSED BY USER ERROR BY STRETCHING OF THE CATHETER DURING APPLICATION CONTRARY TO IFU. [(B)(4)].

    Description of Event or Problem · 1

    FIVE DAYS AFTER IMPLANTATION OF THE CATHETER ICP COULD NOT BE MONITORED. THE PATIENT ALSO HAD IN AN EVD WHICH HAD RECENTLY INCREASED TO AROUND 33MMHG WHICH THEY BROUGHT DOWN TO AROUND 18 WITHIN 20 MINUTES. PATIENT WAS UNCONSCIOUS AND HAD NOT BEEN TRANSPORTED OR REPOSITIONED AS OF LATE---HE WAS POSITIONED SITTING UP IN BED. ATTEMPTING TO RESET USING AN NPS2 OR TO MEASURE WITH A NPS3 DID NOT RESULT IN VALUES ON THE DISPLAY. ONLY THE MASSAGE "SENSOR FAILURE" APPEARED ON THE MONITOR. THE CATHETER WAS NOT REPLACED BY A NEW CATHETER. THE CATHETER WAS EXPLANTED TWO DAYS LATER. HEALTH CONDITION OF THE PATIENT WAS NOT INFLUENCED BY THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274790 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-002

    Patients

    Seq Age Sex Outcome Treatment
    1