BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT PORTABLE NEUROMONITOR (ICP AND ICT)

    MDR report key: 15585365 · Received October 12, 2022

    Report

    Report Number
    2023988-2022-00015
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    September 23, 2022
    Report Date
    November 23, 2022
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWN
    PMA / PMN Number
    K121573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP 001 REF NATUS COMPLAINT# (B)(4). SEVERAL REQUESTS WERE MADE TO CONFIRM IF PRODUCT WOULD BE RETURNED. 21-NOV-2022: CUSTOMER DID NOT RETURN THE PRODUCT. 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. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 58 CONFIRMED COMPLAINTS, GIVING AN INCIDENT RATE OF (B)(4). 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. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 5.10 (B)(4) CAMINO ICP MONITOR RISK ANALYSIS, CONSIDERED TO BE A MODERATE RISK. DEVICE HISTORY RECORD WAS REVIEWED, UNIT HAS PASSED ALL THE REQUIRED TESTS. NO MANUFACTURING OR MATERIAL DEFECTS, NO NON-CONFORMANCES OBSERVED. INSTALL DATE: 30-MAY-2020. FAILLURE CONFIRMED: NO. INVESTIGATION RESULT CODE: SAN DIEGO/EDS PRODUCTS/NO RETURN OF DEVICE FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED AS THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT. THIS COMPLAINT WILL CLOSE, IF THE CUSTOMER DECIDES TO RETURN THE DEVICE THEN ANOTHER COMPLAINT WILL BE GENERATED. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. BASED ON EVALUATION OF THIS COMPLAINT THERE IS NO SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Additional Manufacturer Narrative · 0

    23-SEP-2022: SIEBEL/SALESFORCE SHOWS CUSTOMER'S UNIT DOES NOT DETECT THE CATHETER. CUSTOMER ASKED TO RETURN THE COMPLAINT FORM. CATHETER WAS REMOVED FROM THE PATIENT. 26-SEP-2022: SECOND REQUEST MADE FOR RETURN OF COMPLAINT FORM, ALSO ASKED FOR INFORMATION ON CATHETER. 03-OCT-2022: THIRD ATTEMPT MADE TO COLLECT COMPLAINT FORM. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    PART CAM02: NO CATHETER DETECTED. THE CUSTOMER'S UNIT DOES NOT DETECT THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT. WAITING ON FURTHER FEEDBACK FROM THE CUSTOMER AND TO CONFIRM IF THE PART WILL BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    PART CAM02 - NO CATHETER DETECTED. THE CUSTOMER'S UNIT DOES NOT DETECT THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT. WAITING ON FURTHER FEEDBACK FROM THE CUSTOMER AND TO CONFIRM IF THE PART WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761465 COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) GWN NATUS MEDICAL INCORPORATED CAM02
    2629750 COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) GWN NATUS MEDICAL INCORPORATED CAM02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown