BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT PORTABLE NEUROMONITOR (ICP AND ICT)

    MDR report key: 11063255 · Received December 23, 2020

    Report

    Report Number
    2023988-2020-00021
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 14, 2020
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWM
    PMA / PMN Number
    K121573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    11 JANUARY 2021 (FOLLOW UP 001) (REF NATUS COMPLAINT NO. SR#(B)(4)). CUSTOMER RETURNED THE COMPLAINT FORM AND CONFIRMED THERE WAS NO PATIENT INJURY. CUSTOMER CONFIRMED FAILURE WAS FOUND PRIOR TO PATIENT INVOLVEMENT BUT FEELS LIKE A DEATH OR INJURY COULD OCCUR IF THE MALFUNCTION WERE TO RECUR. CUSTOMER NOTED DELAY IN SURGERY. 22-DEC-2020: PRODUCT WAS RECEIVED IN HOUSE FOR EVALUATION. 27-DEC-2020: PER REPAIR NOTES: "UNIT RETURNED FOR CALIBRATION. PASSED FUNCTIONAL TESTS, CALIBRATION AND ELECTRICAL SAFETY TEST. VISUAL INSPECTION. REPLACED BATTERY. COULD NOT DUPLICATE ANY ERROR. ERROR MAY HAVE BEEN CAUSED BY FAULTY CATHETER. 04-JAN-2021: REVIEW OF PRODUCT EVALUATION FORM SHOWS DHR WAS REVIEWED AND FOUND NO MANUFACTURING DEFECTS OR ASSOCIATED CAPAS. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 28 SIMILAR COMPLAINTS, GIVING AN INCIDENT RATE OF 4.58%. REVIEW OF MEDICAL DEVICE HAZARD ANALYSIS SHOWS INCIDENT TO IDENTIFY AS A NEGLIGIBLE RISK. DEPOT REPAIR DID NOT CONFIRM FAILURE. INVESTIGATION RESULT CODE :SAN DIEGO/EDS PRODUCTS/UNABLE TO CONFIRM REPORT. COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER DOC-033950 CAMINO ICP MONITOR RISK ANALYSIS. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Description of Event or Problem · 0

    TEMPERATURE SENSOR BOARD FAILURE. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    23 DECEMBER 2020 (REF NATUS COMPLAINT NO. SR# (B)(4)) CUSTOMER RETURNED THE COMPLAINT FORM AND CONFIRMED THERE WAS NO PATIENT INJURY. CUSTOMER CONFIRMED FAILURE WAS FOUND PRIOR TO PATIENT INVOLVEMENT BUT FEELS LIKE A DEATH OR INJURY COULD OCCUR IF THE MALFUNCTION WERE TO RECUR. CUSTOMER NOTED DELAY IN SURGERY. REQUESTED AFFECTED PART TO BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    TEMPERATURE SENSOR BOARD FAILURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533789 COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) GWM NATUS MEDICAL INCORPORATED CAM02

    Patients

    Seq Age Sex Outcome Treatment
    1