BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17057167 · Received June 5, 2023

    Report

    Report Number
    3001421318-2023-02128
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 22, 2023
    Report Date
    October 17, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG`S CONCLUSION FOR THIS EVENT: ON THE DEVICE, THE SOFTWARE VERSION 1.1.5 WAS INSTALLED. THE DEVICE DID NOT ALARM BECAUSE IT DID NOT INDICATE ANY TECHNICAL ERRORS AND CONTINUED TO VENTILATE. THE VITAL SIGNS WERE NOT AFFECTED. THE WAVEFORM DISPLAY WAS PARTIALLY AFFECTED. THE GRAPHS WERE ALSO NOT UPDATED OVER AN EXTENDED PERIOD. THE PARTIALLY MISSING DISPLAY OF WAVE-FORMS DOES NOT RESULT IN ANY HARM. ADDITIONALLY, NUMERICAL MONITORING PARAMETERS AND THE CORRESPONDING ALARMING SYSTEM WERE FULLY FUNCTIONAL. THE CAUSE FOR THIS SOFTWARE DISCREPANCY IS ALREADY RESOLVED WITH AN UPGRADE TO SOFTWARE VERSION 1.2.1. A LOGFILE ANALYSIS WAS PERFORMED BUT NO ENTRIES IN THE LOG FILES REGARDING THIS SITUATION COULD BE FOUND. SINCE THE DEVICE DID NOT ALARM, NO ERROR WAS ENTERED IN THE LOG FILE. NO HARDWARE WAS SENT BACK. THE ROOT CAUSE WAS DETERMINED TO BE A SOFTWARE ERROR. IN CONSEQUENCE THE DEVICE WAS UPGRADED TO THE LATEST SOFTWARE VERSION. THERE WAS NO PATIENT OR USER HARM REPORTED. CORRECTION: SOFTWARE UPDATE TO 1.2.1.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG`S CONCLUSION FOR THIS EVENT: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: CURVES AND ANIMATION NOT VISIBLE DURING VENTILATION. NO ALARM OR TF. SUMMARY: ONLY PARTS OF THE DISPLAY VISIBLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: CURVES AND ANIMATION NOT VISIBLE DURING VENTILATION. NO ALARM OR TF. SUMMARY: ONLY PARTS OF THE DISPLAY VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463380 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown