BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVENT-P

    MDR report key: 8063755 · Received November 13, 2018

    Report

    Report Number
    3006942548-2018-00005
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 13, 2018
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    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

    AFTER IMPLANTATION OF THE CATHETER ICP COULD BE MONITORED FOR 1 HOUR. AFTERWARDS ICP MEASUREMENT WAS NO MORE POSSIBLE. SO THE CATHETER WAS REPLACED BY A NEW CATHETER. NO ADDITIONAL ANESTHESIA AND NO ADDITIONAL MEDICINAL TREATMENT WAS NECESSARY. HEALTH CONDITION OF THE PATIENT WAS NOT INFLUENCED BY THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902510 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-001

    Patients

    Seq Age Sex Outcome Treatment
    1