BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON-C3

    MDR report key: 18844814 · Received March 6, 2024

    Report

    Report Number
    3001421318-2024-00526
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 28, 2024
    Report Date
    November 22, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT AS TECHNICAL PROBLEMS WITH AIR LEAKAGE OF THE TRACHEAL CANNULA (TC) CUFF DURING VENTILATION OF THE PATIENT COULD BE IDENTIFIED. WITH THIS INVESTIGATION IT HAS NOT BEEN CONFIRMED THAT THE VENTILATOR DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. THE VENTILATION THERAPY FAILED DURING VENTILATION BECAUSE OF AN AIR LEAKAGE WHEN USING A TRACHEAL CANNULA (TC). THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE DEVICE FAILED DURING VENTILATION AND HAD TO BE REPLACED. AS A RESULT THE VENTILATED 90 YEAR OLD PATIENT HAD TO BE REANIMATED BECAUSE HIS CIRCULATION WAS POOR. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT HAS POTENTIAL TO CAUSE SERIOUS INJURY OR DEATH, IF IT WERE TO RECUR DURING THE USE WITH A PATIENT. THEREFORE, THE EVENT HAS BEEN DEEMED TO BE A REPORTABLE EVENT. THE ROOT CAUSE WAS ATTRIBUTED TO TECHNICAL PROBLEMS WITH AIR LEAKAGE OF A TC CUFF DURING VENTILATION OF THE PATIENT. THE PROBLEMS PERSISTED AFTER THE EXCHANGE FOR A SECOND TRACHEAL CANNULA, BUT WERE NOT CAUSED BY A DIRECT FAILURE OF THE HAMILTON-C3 VENTILATION DEVICE. FOLLOWING THE EVENT, THE DEVICE WAS TESTED BY A FIELD SERVICE TECHNICIAN AND NO TECHNICAL FAILURES WERE OBSERVED. THE DEVICE WAS TESTED OK, BUT REMAINS BLOCKED UNTIL CLOSURE OF THE INVESTIGATION BY HAMILTON MEDICAL AG. THERE WERE NO SIMILAR CASES FOR A HAMILTON-C3 DEVICE ON RECORD. IN ADDITION, THE ROOT CAUSE WAS ATTRIBUTED TO TECHNICAL APPLICATION PROBLEMS WITH AIR LEAKAGE OF THE TRACHEAL CANNULA (TC) CUFF, WHICH WAS NOT AVAILABLE FOR FURTHER INVESTIGATION (CONSUMABLE), NO FURTHER INVESTIGATION FOR IMPROVEMENT CAN BE PERFORMED AND A CAPA WILL NOT NEED TO BE INITIATED, EVEN THOUGH THE EVENT IS HANDLED AS A DSI CASE. NEVERTHELESS, THE FAILURES OF DEVICES IN THE MARKET ARE MONITORED CONSTANTLY AND IF THE FAILURE RATE WAS TO INCREASE A CAPA WILL BE CONSIDERED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT AS TECHNICAL PROBLEMS WITH AIR LEAKAGE OF THE TRACHEAL CANNULA (TC) CUFF DURING VENTILATION OF THE PATIENT COULD BE IDENTIFIED. WITH THIS INVESTIGATION IT HAS NOT BEEN CONFIRMED THAT THE VENTILATOR DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. THE VENTILATION THERAPY FAILED DURING VENTILATION BECAUSE OF AN AIR LEAKAGE WHEN USING A TRACHEAL CANNULA (TC). THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE DEVICE FAILED DURING VENTILATION AND HAD TO BE REPLACED. AS A RESULT THE VENTILATED (B)(6) PATIENT HAD TO BE REANIMATED BECAUSE HIS CIRCULATION WAS POOR. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT HAS POTENTIAL TO CAUSE SERIOUS INJURY OR DEATH, IF IT WERE TO RECUR DURING THE USE WITH A PATIENT. THEREFORE, THE EVENT HAS BEEN DEEMED TO BE A REPORTABLE EVENT. THE ROOT CAUSE WAS ATTRIBUTED TO TECHNICAL PROBLEMS WITH AIR LEAKAGE OF A TC CUFF DURING VENTILATION OF THE PATIENT. THE PROBLEMS PERSISTED AFTER THE EXCHANGE FOR A SECOND TRACHEAL CANNULA, BUT WERE NOT CAUSED BY A DIRECT FAILURE OF THE HAMILTON-C3 VENTILATION DEVICE. FOLLOWING THE EVENT, THE DEVICE WAS TESTED BY A FIELD SERVICE TECHNICIAN AND NO TECHNICAL FAILURES WERE OBSERVED. THE DEVICE WAS TESTED OK, BUT REMAINS BLOCKED UNTIL CLOSURE OF THE INVESTIGATION BY HAMILTON MEDICAL AG. THERE WERE NO SIMILAR CASES FOR A HAMILTON-C3 DEVICE ON RECORD. IN ADDITION, THE ROOT CAUSE WAS ATTRIBUTED TO TECHNICAL APPLICATION PROBLEMS WITH AIR LEAKAGE OF THE TRACHEAL CANNULA (TC) CUFF, WHICH WAS NOT AVAILABLE FOR FURTHER INVESTIGATION (CONSUMABLE), NO FURTHER INVESTIGATION FOR IMPROVEMENT CAN BE PERFORMED AND A CAPA WILL NOT NEED TO BE INITIATED, EVEN THOUGH THE EVENT IS HANDLED AS A DSI CASE. NEVERTHELESS, THE FAILURES OF DEVICES IN THE MARKET ARE MONITORED CONSTANTLY AND IF THE FAILURE RATE WAS TO INCREASE A CAPA WILL BE CONSIDERED. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: EXPIRATION ZU NIEDRIG, GERÄT STELLTE DIE BEATMUNG EIN, IN IN DER FOLGE MUSSTE DER BEATMETE PATIENT REANIMIERT WERDEN. AM (B)(6) 2023 IST E EINE FEHLERAUSLESUNG AM GERÄT SEITENS DES HÄNDLERS GEPLANT. TRANSLATED WITH DEEPL.COM: EXPIRATION TOO LOW, DEVICE STOPPED VENTILATING, AS A RESULT THE VENTILATED PATIENT HAD TO BE RESUSCITATED. A FAULT READOUT ON THE DEVICE IS PLANNED BY THE DEALER ON (B)(6) 2023.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: EXPIRATION ZU NIEDRIG, GERÄT STELLTE DIE BEATMUNG EIN, IN IN DER FOLGE MUSSTE DER BEATMETE PATIENT REANIMIERT WERDEN. AM 05.03.2023 IST E EINE FEHLERAUSLESUNG AM GERÄT SEITENS DES HÄNDLERS GEPLANT. TRANSLATED WITH DEEPL.COM: EXPIRATION TOO LOW, DEVICE STOPPED VENTILATING, AS A RESULT THE VENTILATED PATIENT HAD TO BE RESUSCITATED. A FAULT READOUT ON THE DEVICE IS PLANNED BY THE DEALER ON 5 MARCH 2023.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: EXPIRATION ZUNIEDRIG, GERÄT STELLTE DIE BEATMUNG EIN, IN DER FOLGE MUSSTE DER BEATMETE PATIENT REANIMIERT WERDEN. AM (B)(6) 2023 IST E EINE FEHLERAUSLESUNG AM GERÄT SEITENS DES HÄNDLERS GEPLANT. TRANSLATED WITH DEEPL.COM: EXPIRATION TOO LOW, DEVICE STOPPED VENTILATING, AS A RESULT THE VENTILATED PATIENT HAD TO BE RESUSCITATED. A FAULT READOUT ON THE DEVICE IS PLANNED BY THE DEALER ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110698 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention