BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18461989 · Received January 8, 2024

    Report

    Report Number
    3001421318-2023-13129
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    June 27, 2022
    Report Date
    January 5, 2024
    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: 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. IN FUTURE HAMILTON MEDICAL AG WILL REPORT 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 PREPARED FOR TREATMENT. THE ROOT CAUSE CANNOT FULLY BE DETERMINED, AS NO FURTHER ANALYSIS WERE CARRIED OUT. AS A SOFTWARE UPDATE SOLVED THE PROBLEM, THE MOST LIKELY CAUSE WAS A SOFTWARE ERROR. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    UNABLE TO SELECT 3.0.3 UNDER PRODUCT INFO ON CER THIS UNIT HAS 3.0.3 SOFTWARE DURING START UP VENT WILL ACTIVE BUZZER WHEN THERE IS A YELLOW ALARM. IF YOU HIT THE ALARM SILENCE BUTTON THE BUZZER WILL STOP AND WILL NOT REACTIVATE WHEN THE ALARM SILENCE ENDS. IF NO ALARM IS ACTIVE DURING START UP THEN THE BUZZER WILL NOT ACTIVATE. WILL SEND VIDEOS THREW FILE SHARE TO SVEN. TOO BIG TO UPLOAD TO CER. SAME ISSUE AS CER# 101170 & 101142

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619912 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown