BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16597699 · Received March 23, 2023

    Report

    Report Number
    3001421318-2023-00840
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    March 11, 2021
    Report Date
    October 5, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K201306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS NO, 2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES.A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS USED ON A PATIENT. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE AN AGED/ DEFECTIVE BATTERY DUE TO LACK OF MAINTENANCE. NO IMMEDIATE CONFIRMED CORRECTION WAS PERFORMED. THERE WAS A REPORTED POTENTIAL PATIENT HARM DUE TO OXYGEN DESATURATION.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. REPORTED BY USER OUTSIDE THE US. REPORT REFERENCE (B)(4). THE REPORT FROM HOSPITAL SAYS: "WHEN USING NON-INVASIVE VENTILATION ON THE CCU C1 BED IN THE DEPARTMENT OF CARDIOLOGY, AFTER THE "TECHNICAL FAILURE 431001, 485001, 446025" ALARM OCCURRED, THE SCREEN SHOWED A VENTILATION FAILURE, THE VENTILATOR COULD NOT VENTILATE NORMALLY, THE PATIENT FELT CHEST TIGHTNESS, AND THE BLOOD OXYGEN SATURATION BEGAN TO DECREASE HAMILTON-C1 MADE IN 2013. IMMEDIATELY GIVE OXYGEN TO THE MASK AND REPLACE THE VENTILATOR. CHECK THE MALFUNCTIONING VENTILATOR AND FOUND THAT THE FLOW SENSOR, THE AIRTIGHTNESS TEST, AND THE OXYGEN BATTERY ALL PASSED, AND THE EQUIPMENT DEPARTMENT WAS NOTIFIED BY TELEPHONE FOR MAINTENANCE". THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT IS LIKELY TO CAUSE SERIOUS INJURY OR DEATH TO PATIENT. FURTHERMORE IS THE ISSUE NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT COULD CAUSE SERIOUS INJURY OR DEATH IF IT WERE TO REOCCUR.

    Description of Event or Problem · 0

    WHEN USING NON-INVASIVE VENTILATION ON THE CCU C1 BED IN THE DEPARTMENT OF CARDIOLOGY, AFTER THE "TECHNICAL FAILURE 431001, 485001, 446025" ALARM OCCURRED, THE SCREEN SHOWED A VENTILATION FAILURE, THE VENTILATOR COULD NOT VENTILATE NORMALLY, THE PATIENT FELT CHEST TIGHTNESS, AND THE BLOOD OXYGEN SATURATION BEGAN TO DECREASE HAMILTON-C1 MADE IN 2013

    Description of Event or Problem · 0

    WHEN USING NON-INVASIVE VENTILATION ON THE CCU C1 BED IN THE DEPARTMENT OF CARDIOLOGY, AFTER THE "TECHNICAL FAILURE 431001, 485001, 446025" ALARM OCCURRED, THE SCREEN SHOWED A VENTILATION FAILURE, THE VENTILATOR COULD NOT VENTILATE NORMALLY, THE PATIENT FELT CHEST TIGHTNESS, AND THE BLOOD OXYGEN SATURATION BEGAN TO DECREASE HAMILTON-C1 MADE IN 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27930 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention