BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18851807 · Received March 6, 2024

    Report

    Report Number
    3001421318-2023-42105
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    November 23, 2022
    Report Date
    March 6, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K153046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION LED TO AN INOPERABLE DEVICE. THE ROOT CAUSE IS A MALFUNCTION OF AN ELECTRICAL COMPONENT. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. 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

    THE VENT DIDN'T POWER ON AND A HIGH PITCH SOUND WAS ALARMING INSTEAD. BIOMED HAD TO PRESS AND HOLD THE POWER BUTTON FOR A WHILE UNTIL THE ALARM WOULD STOP. ONCE THE ALARM STOPPED, BIOMED WAS ABLE TO POWER ON THE DEVICE WITH NO ISSUE. ACCORDING TO STAFF, THE DEVICE WAS NOT PLUGGED TO AC POWER WHEN THEY HAVE ATTEMPTED TO POWER ON THE DEVICE. THEY ENCOUNTERED THE SAME ISSUE LAST YEAR ON OCTOBER 21, 2021 AND NOVEMBER 7, 2022. BOMIMED COULDN'T FIND ANY FAULT IN THE ERROR LOG AND THE BATTERIES WERE REPLACED. THE VENT WAS RECENTLY PMD AND THE BATTERIES WERE REPLACED ON NOVEMBER 1, 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195592 HAMILTON MEDICAL AG HAMILTON-MR1 CBK HAMILTON MEDICAL AG HAMILTON-MR1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown