BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 18187372 · Received November 21, 2023

    Report

    Report Number
    2023988-2023-00042
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    September 20, 2023
    Report Date
    February 12, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWM
    UDI-DI
    00382830047494
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT (B)(4). THERE ARE NO CAPA'S RELATED TO THIS ISSUE. PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. PER (B)(4) CAMINO PRESSURE MONITORING CATHETER KITS-RISK ANALYSIS SPREADSHEET, HAZARD ID - 12.1, THE RISK IS CONSIDERED LOW. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). CORRECTION TO SECTION D4, LOT 118D00643292, SERIAL (B)(6). THE DEVICE HISTORY RECORD WAS REVIEWED, THE RAW MATERIALS USED IN THE MANUFACTURING MET SPECIFICATIONS AND THERE WERE NO ANOMALIES OBSERVED DURING THE MANUFACTURING , PACKAGING, OR INSPECTION OF THE DEVICE IN PROCESS. COMPLAINT HISTORY REVIEW: 1 PREVIOUSLY CONFIRMED 'INTEG-IMPROPER FUNCTION' COMPLAINTS WITHIN THE PAST TWO YEARS. THE COMPLAINT COULD NOT BE CONFIRMED, THE DEVICE WAS RETURNED AND FUNCTIONALLY TESTED, MEETING SPECIFICATIONS. THE COMPLAINT COULD NOT BE DUPLICATED, CATHETER FUNCTIONED AS INTENDED. FAILURE MODE: UNCONFIRMED / CATHETER MET SPECIFICATION, NO FAULT FOUND.

    Description of Event or Problem · 0

    PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - PATIENT HAD SINGLE LUMEN INTRACRANIAL BOLT INSERTED OVERNIGHT, REQUIRED USE OF CAMINO MONITOR FOR ICP (INTRACRANIAL PRESSURE) READINGS. WHEN CATHETER INSERTED AND CONNECTED TO CAMINO, "CATHETER ERROR" MESSAGE WAS RECEIVED. STAFF ATTEMPTED TO USE SECOND CAMINO MONITOR, RECEIVED SAME ERROR MESSAGE "CATHETER FAILURE". PATIENT REQUIRED SURGERY AND WAS SENT TO THE OR WITH THE CATHETER IN PLACE, SECONDARY PORTION OF MONITORING DEVICE WAS KEPT, CATHETER WAS DISCARDED.

    Description of Event or Problem · 0

    PART1104B -OLM INTRACRANIAL PRESSURE MONITORING KIT - PATIENT HAD SINGLE LUMEN INTRACRANIAL BOLT INSERTED OVERNIGHT, REQUIRED USE OF CAMINO MONITOR FOR ICP (INTRACRANIAL PRESSURE) READINGS. WHEN CATHETER INSERTED AND CONNECTED TO CAMINO,"CATHETER ERROR" MESSAGE WAS RECEIVED. STAFF ATTEMPTED TO USE SECOND CAMINO MONITOR, RECEIVED SAME ERROR MESSAGE "CATHETER FAILURE". PATIENT REQUIRED SURGERY AND WAS SENT TO THE OR WITH THE CATHETER IN PLACE, SECONDARY PORTION OF MONITORING DEVICE WAS KEPT, CATHETER WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986407 OLM INTRACRANIAL PRESSURE MONITORING KIT OLM INTRACRANIAL PRESSURE MONITORING KIT GWM NATUS MEDICAL INCORPORATED 1104B 118D00643292 00382830047494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown