BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18871930 · Received March 10, 2024

    Report

    Report Number
    3001421318-2023-42414
    Event Type
    Malfunction
    Date Received
    March 10, 2024
    Date of Event
    November 5, 2022
    Report Date
    March 9, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    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: 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 IN USE. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED, THE ISSUE COULD NOT BE REPRODUCED. THE SERVICE TECHNICIAN RAN THE SERVICE SOFTWARE, AND THE DEVICE PASSED ALL TESTS. THE DEVICE WAS THEN RUN IN FUNCTION MODE AND SHOWED NO ISSUES. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    HAVE A CUSTOMER THAT HAS BEEN ONGOING ISSUES WITH 'EXHALATION OBSTRUCTED' ALARMS INTERMITTENT WITH NEONATAL TRANSPORT. THIS ISSUE SEEMS TO BE ISOLATED TO NICU TRANSPORT AND HASN'T BEEN APPEARING IN PEDS DEMOGRAPHIC. ORIGINALLY BOMIMED THOUGHT THIS WAS AN ISSUE WITH FILTER ON EXP. SIDE HOWEVER IN RECENTLY WEEKS SITE HAS REMOVED FILTER AND ARE STILL SEEING ISSUES. BELOW IS LATEST DESCRIPTION OF ERROR: ALSO I HAVE ATTACHED VIDEO FROM BACK IN SEPTEMBER ON ANOTHER T1 (SN 4779) WHEN ISSUE WAS HAPPENING. EXHALATION OBSTRUCTION ALARM REPEATED WITH VT DELIVERY INTERRUPTED WITH A FLUSHING OF INTERNAL PERIODICALLY EO ALARM GOING OFF. NOTE: THIS IS WITH THE PATIENT WHO IS VENTILATED AT 2 MLS WE SWITCHED TO PRESSURE VENTILATION WITH EXHALATION OBSTRUCTED ALARM GOING OFF ONLY ONCE DURING OUR TRANSPORT TO THE UAH FROM THE RAH. THIS ALARM MAY ONLY BE NORMAL WITH VENT WITH TIDAL VOLUMES THAT MAY NOT QUITE REACH 2 MLS. JUST THE INTERRUPTION OF THE VT DELIVERY WITH THE VENTILATOR DOING A FLUSHING STUCK IS AH ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176981 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown