BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVENT-P-TEMP

    MDR report key: 10676421 · Received October 14, 2020

    Report

    Report Number
    3006942548-2020-00005
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    July 27, 2020
    Report Date
    September 17, 2020
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR EVALUATION OF THE MALFUNCTION DHR DOCUMENTS WERE REVIEWED. THEY DEMONSTRATE THAT THE CATHETER NEUROVENT_P_TEMP ((B)(4)) MET SPECIFICATION DURING MANUFACTURING. FINAL INSPECTION OF THE FINISH CATHETER WAS PASSED. THIS DEMONSTRATES THAT THE CATHETER HAS BEEN MANUFACTURED AND SOLD CONFORMANCE TO RELEVANT SPECIFICATIONS. FURTHERMORE RETURNED CATHETER WAS INVESTIGATED. AN INITIAL CHECKUP IN AIR AT ROOM TEMPERATURE AND IN A WATER BATH 37°C WAS PERFORMED. THE CATHETER HAS SHOWN AN ICP VALUE OF APPROX. 73,9 MMHG, WHICH IS OUT OF SPECIFICATION. FOR A FURTHER INVESTIGATION, THE CONNECTOR WAS OPENED AND VISUALLY INSPECTED TO CHECK IF THE PCB WAS EXPOSED TO MOISTURE OR A HIGH PULLING FORCE. THREE WIRES WERE TORN OFF. THE MISSING WIRE RESERVE (PULL LOOP OF APPROX. 6-8 CM MICRO CABLE) IN THE PLUG INDICATES AN OVERSTRETCHING OF THE CATHETER. BY OVERSTRETCHING, THE WIRE RESERVE IS DRAWN INTO THE CATHETER UNTIL A WIRE IS TORN OFF. THIS TORN OFF WIRES EXPLAIN THE STATIC PRESSURE VALUE. TO FINALIZE TECHNICAL ANALYSIS, IT WAS INVESTIGATED, IF THE MICROCHIP SHOWS ANY SIGNS OF MECHANICAL DAMAGE, THE MEASUREMENT WINDOW WAS VISUALLY INSPECTED, NO DAMAGE TO THE SILICONE SURFACE COULD BE DETERMINED. CONCLUSION: THIS ISSUE IS ATTRIBUTED AS A HANDLING ERROR ON THE PART OF THE USER, SINCE PRECAUTIONARY MEASURES AND NOTES ACC. THE INSTRUCTIONS FOR USE ZWO-013 HAVE NOT BEEN SUFFICIENTLY OBSERVED.

    Description of Event or Problem · 1

    THE CLINIC INFORMED US THAT THE CATHETER NEUROVENT-P-TEMP (B)(4) WAS NOT ABLE TO DISPLAY ICP VALUES WHILE CONNECTED TO MONITOR. THE CLINIC DECIDED TO REMOVE THE CATHETER AND NO NEW CATHETER TO APPLICATE. THE HEALTH CONDITION OF THE PATIENT WAS NOT INFLUENCED BY THIS EVENT. NO ADDITIONAL OPERATION AND MEDICINE WERE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145762 NEUROVENT-P-TEMP NEUROLOGICAL CATHETER GWM RAUMEDIC AG 094268-001

    Patients

    Seq Age Sex Outcome Treatment
    1