BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18109024 · Received November 10, 2023

    Report

    Report Number
    3001421318-2023-16180
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    February 25, 2022
    Report Date
    November 8, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    RESPIRATORY STATED THAT DURING A PATIENT VENTILATION, THE PATIENT KNOCKED OVER THE VENTILATOR WHICH CAUSED THE VENT TO TURN OFF. THE PATIENT WAS NOT HARMED. THE DEVICE IS UNABLE MOVE PASS THE START UP WINDOW AND HAS A CONTINUOUS ALARM. A DIFFERENT T1 VENTILATOR WAS USED ON THE PATIENT. FAILURE AND ALARMS WERE DUPLICATED BY THE HAMILTON MEDICAL INC SERVICE TECHNICIAN. THE VENTILATOR IS UNABLE TO TAKE SCREENSHOTS AND EXPORT THE DEVICE'S FILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806148 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown