BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16704166 · Received April 7, 2023

    Report

    Report Number
    3001421318-2023-00955
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    September 30, 2020
    Report Date
    June 5, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. DEVICE ALARMS WITH A HIGH PRIORITY TECHNICAL EVENT: 231008 O2 VALVE LEAK. PHASE: SELF TEST/VENTILATION. NO PATIENT INVOLVED. NO HARM TO PATIENT OR USER. PROLONGED EXPOSURE TO HIGH OXYGEN CONCENTRATIONS MAY CAUSE HYPEROXEMIA. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT IS LIKELY TO CAUSE SERIOUS INJURY OR DEATH TO PATIENT OR USER. FURTHERMORE IS THE ISSUE NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT IS LIKELY TO CAUSE SERIOUS INJURY OR DEATH TO PATIENT OR USE IF IT WERE TO RECUR.

    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. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION 'TECHNICAL EVENT:231008' DUE TO LEAKY O2 VALVE CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED. A NEW VENTILATOR NEEDS TO BE PREPARED. THE ROOT CAUSE OF THE VENTILATOR TO ALARM WITH "TECHNICAL EVENT:231008" WAS A MALFUNCTION OF THE O2 MIXER VALVE CAUSING A LEAK. (MECHANICALLY JAMMED DUE STORAGE OF THE DEVICE FOR A LONG PERIOD BEFORE USAGE). WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS PREPARED TO BE USED FOR TREATMENT OR DIAGNOSIS (PREOP CHECK). THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    APPEARS TECHNICAL EVENT 231008 & 231001 ON SCREEN DUE TO O2 VALVE LEAK.

    Description of Event or Problem · 0

    APPEARS TECHNICAL EVENT 231008 & 231001 ON SCREEN DUE TO O2 VALVE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752866 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown