BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT

    MDR report key: 20722328 · Received November 19, 2024

    Report

    Report Number
    2023988-2024-00080
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 28, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWN
    UDI-DI
    00382830047531
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). NO ASSOCIATED CAPAS. COMPLAINT HISTORY REVIEW/TREND ANALYSIS: (24 MONTHS REVIEW AND PERCENT OF SALES) 0 PREVIOUSLY CONFIRMED "INTEG-PRESSURE" COMPLAINTS WITHIN THE PAST TWO YEARS. (B)(4).1104HMT UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE =(B)(4). RISK MANAGEMENT REVIEW: (IDENTIFY HAZARD ID) A REVIEW OF (B)(4).MEDICAL DEVICE HAZARD ANALYSIS (REV 05), IDENTIFIES THE HAZARD SITUATION AS "12.23 DOES NOT MEASURE INTRACRANIAL PRESSURE ACCURATELY: NON-ROBUST MODULE END ELECTRONICS DESIGN OR MATERIALS / FOR INTENDED USE" BASED ON COMPLAINT OF "PRESSURE NOT READING." THE RISK LEVEL IS CONSIDERED LOW. THIS DETERMINATION IS BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER. ROOT CAUSE/FAILURE INVESTIGATION: THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR PROVIDE ANY FURTHER INFORMATION REGARDING THE ALLEGED COMPLAINT. FAILURE MODE: NO DEVICE RETURNED - UNABLE TO DETERMINE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). 07-NOV-2024: NATUS RECEIVED NOTICE OF DISPLAY ISSUE ON CAM02, SN: (B)(6). USER COULD NOT CONTINUE WITH PROCEDURE DUE TO PRESSURE ISSUES. DEVICE NEEDED TO BE CHANGED, CAUSING A DELAY IN PROCEDURE. THE CATHETER WAS REPLACED. THIS CAMINO SYSTEM CAM02, SN: (B)(6). USED AT THE TIME IS PAST DUE FOR THE YEARLY CALIBRATION ON (B)(6) 2022. FURTHER REVIEW OF COMPLAINT DETAILS TO BE CARRIED OUT.

    Description of Event or Problem · 0

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - USER COULD NOT CONTINUE WITH PROCEDURE DUE TO PRESSURE ISSUES. THE PATIENT WAS ADMITTED TO THE NEUROSURGERY WARD OF THE HOSPITAL DUE TO CEREBRAL HERNIA. THE PATIENT WAS SCHEDULED FOR SURGERY. INTRAOPERATIVE INTRACRANIAL PRESSURE MONITORING COULD NOT MEASURE THE PRESSURE, THE OPERATION WAS DELAYED, AND THE READING RETURNED TO NORMAL AFTER REPLACING NEW DEVICES. NO INJURIES.

    Description of Event or Problem · 0

    MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - USER COULD NOT CONTINUE WITH PROCEDURE DUE TO PRESSURE ISSUES. THE PATIENT WAS ADMITTED TO THE NEUROSURGERY WARD OF THE HOSPITAL DUE TO CEREBRAL HERNIA. THE PATIENT WAS SCHEDULED FOR SURGERY. INTRAOPERATIVE INTRACRANIAL PRESSURE MONITORING COULD NOT MEASURE THE PRESSURE, THE OPERATION WAS DELAYED, AND THE READING RETURNED TO NORMAL AFTER REPLACING NEW DEVICES. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323946 MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT GWN NATUS MEDICAL INCORPORATED 1104HMT 00382830047531

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female