BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT

    MDR report key: 12018409 · Received June 17, 2021

    Report

    Report Number
    2023988-2021-00013
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 24, 2021
    Report Date
    August 13, 2021
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). REQUEST FOR PRODUCT RETURN WAS MADE (B)(6) 2021. CUSTOMER DID NOT RETURN THE PRODUCT THEREFORE UNABLE TO PERFORM FUNCTIONAL TESTING. REVIEW OF PRODUCT EVALUATION FORM SHOWS NO ASSOCIATED CAPAS. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 1 CONFIRMED COMPLAINT, GIVING AN INCIDENT (B)(4). REVIEW OF MEDICAL DEVICE HAZARD ANALYSIS SHOWS INCIDENT TO IDENTIFY AS AN ACCEPTABLE RISK. DEPOT REPAIR COULD NOT CONFIRM FAILURE AS PRODUCT WAS NOT RETURNED. THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER QMS-004442 COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 5.10 DOC-033950 CAMINO ICP MONITOR RISK ANALYSIS. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 12.1 DOC-033950 CAMINO ICP MONITOR RISK ANALYSIS. REVIEW OF DEVICE HISTORY RECORD SHOWS THAT THE UNIT DID NOT SHOW ANY ANOMALIES OR NONCONFORMANCES RELATED TO THE COMPLAINT, PRODUCT MET SPECIFICATIONS BEFORE RELEASE. SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED PER QMS-004442. A SEPARTE REPORT WAS OPENED TO INVESTIGATE THE COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) - PART CAM02 (REF MFR REPORT# 2023988-2021-00012). CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    CUSTOMER DOCUMENTED INCONSISTENT ICP MEASUREMENTS INVOLVING 1104BT CATHETER. NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF NATUS COMPLAINT# (B)(4). CUSTOMER DOCUMENTED INCONSISTENT ICP MEASUREMENTS INVOLVING THE CAM02 AND 1104BT CATHETER (TEMPERATURE MEASURED OK). CUSTOMER STATES THE FIRST CATHETER INDICATED INTRACRANIAL HYPERTENSION, HOWEVER THE NEUROSURGEON DID NOT AGREE. CATHETER WAS REMOVED AFTER THREE DAYS, SECOND CATHETER BEGAN TO SHOW A HIGH VALUE AND THEN WENT FLAT. THE CAM02 THEN STOPPED SENSING BOTH THE "PIC AND TEMPERATURE". AFTER CATHETER WAS REMOVED, THE MONITOR DISPLAYED ERROR MESSAGE INDICATING "SENSOR BOARD FAILURE". CUSTOMER PROVIDED ADDITIONAL BACKGROUND INFORMATION CONFIRMING THE FOLLOWING: BOTH CATHETERS WERE ZEROED PRIOR TO INSERTION. CAMCABL WAS NOT REPLACED DURING PATIENT MONITORING. CUSTOMER HAS ANOTHER CAM02 MONITOR TO USE. CALIBRATION WAS DUE (B)(6) OF 2020, HOWEVER CUSTOMER STATES THE UNIT WAS JUST INSTALLED IN (B)(6) 2020 AND HAS ONLY BEEN USED FOR 6 MONTHS. IT IS YET TO DETERMINE IF THE CATHETERS HAD ANY PROBLEM OR IF IT WAS THE MONITOR FAILURE THAT CAUSED ALL THE TROUBLE WITH THIS MONITORING CASE, EVEN THOUGH THE ERROR APPEARED AT THE END AFTER REMOVING THE PATIENT MONITORING. A SEPARATE REPORT HAS BEEN OPENED TO INVESTIGATE THE COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) - PART CAM02 (REF MFR REPORT# 2023988-2021-00012). AFFECTED PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER DOCUMENTED INCONSISTENT ICP MEASUREMENTS INVOLVING 1104BT CATHETER. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918450 INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT GWM NATUS MEDICAL INCORPORATED 1104BT 118D00402093

    Patients

    Seq Age Sex Outcome Treatment
    1