BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17850219 · Received October 2, 2023

    Report

    Report Number
    3001421318-2023-28559
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    April 28, 2020
    Report Date
    September 29, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 WAS DETERMINED TO BE A FAULTY POWER SUPPLY. IN CONSEQUENCE THE CORRECTION TO REPLACE THE POWER SUPPLY RESOLVED THE ISSUE. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    CAN YOU PLEASE TAKE A LOOK AT THE ATTACHED LOG. THE CUSTOMER REPORTED THAT THE T1 SHUT DOWN DURING AN INTERNAL TRANSFER. THERE IS NO EVIDENCE OF THIS IN THE LOG. THERE IS HOWEVER CONCERNING DATA IN THE LOG. ITEM 626 TURN FLOW SENSOR ITEM 200-201 AC TO BATTERY THEN BATTERY AT 15% WE CANNOT DETERMINE WHEN VENTILATION BEGAN AS THE LOG IS INCOMPLETE WITH NOTHING FROM WHEN THE PATIENT WAS PUT ON THE VENT. I REMOVED THE VENTILATOR AND RAN IT ON BATTERY IN MY OFFICE WITHOUT ANY PROBLEMS AS YOU WILL SEE FROM THE SECOND LOG FILE. I HAVE SINCE RAN THE VENTILATOR FOR 24 HOURS CONTINUOUSLY INTERMITTENTLY SWITCHING TO BATTERY AND BACK TO AC WITHOUT ANY PROBLEMS. CAN YOU TELL ME WHY THE LOG FILE IS TRUNCATED ONLY BEGINNING ON THE 26TH WITH 999/2020-04-26 19:22:12/!!! /HIGH MINUTE VOLUME DO THE MILITARY T1 ONLY HOLD 1000 LOG FILE ENTRIES? IS THERE ANY WAY TO GET THE FULL LOGS?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099316 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown