BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16395149 · Received February 17, 2023

    Report

    Report Number
    3001421318-2023-00239
    Event Type
    Death
    Date Received
    February 17, 2023
    Date of Event
    August 16, 2021
    Report Date
    September 11, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES.  REPORTED BY USER WITHIN US. REPORT REFERENCE 0002937708-2021-00010. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL CONTINUE REPORTING AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. 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. THE ROOT CAUSE WAS DETERMINED TO BE A SATURATED EXPIRATORY BACTERIA FILTER ON THE EXPIRATION VALVE THAT OBSTRUCTED EXHALATION OF THE PATIENT (THE HOSPITAL WAS WARNED A WEEK BEFORE THE EVENT NOT TO USE THAT TYPE OF FILTERS) AND NO ACTION WAS TAKEN TO REMOVE THE FILTER IMMEDIATELY WHEN "EXHALATION OBSTRUCTED" ALARMS WERE SOUNDED REPEATEDLY, AS INSTRUCTED IN THE OPERATOR'S MANUAL. AS A PREVENTIVE ACTION THE EXPIRATORY VALVE PART NUMBER 10089440 (RGA 76253) HAS BEEN REPLACED. THE PROBLEM SHOWED NO DIRECT OR INDIRECT INDICATION OR CORRELATION THAT A MALFUNCTION COULD BE RELATED TO THE EXHALATION VALVE. RATHER, THE PROBLEM WAS DUE TO AN OVER-MOISTURE-SATURATED FILTER CONNECTED TO THE EXHALATION PORT AND REPLACED TOO LATE. "THE PATIENT WAS DYING AND DID NOT RECOVER O2 SATURATION AFTER THE EVENT", AS STATED BY THE RT DIRECTOR. THE EVENT HAS BEEN REPORTED TO THE FDA.

    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. REPORT REFERENCE 0002937708-2021-00010. VENTILATOR ALARMED EXHALATION OBSTRUCTED. VENTILATION NOT POSSIBLE. PATIENT DIED. THE BIOMED SAID THAT THE FILTER IN THE EXHALATION LIMB WAS SATURATED. 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

    VENTILATOR ALARMED EXHALATION OBSTRUCTED.

    Description of Event or Problem · 0

    VENTILATOR ALARMED EXHALATION OBSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116088 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death