BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18561272 · Received January 23, 2024

    Report

    Report Number
    3001421318-2023-20974
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    August 5, 2021
    Report Date
    January 22, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 LIKE 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 DURING THE PRE- OPERATIONAL CHECKS. THE EXACT ROOT CAUSES COULD NOT BE DETERMINED. AS MOST LIKELY CAUSE IT HAS BEEN IDENTIFIED TO BE THE INTERNAL FLOW SENSOR AIR. THE DRIVER BOARD AS CAUSE IS UNLIKELY BUT CANNOT BE EXCLUDED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    UNIT SENT INTO THE WORKSHOP FOR FAILING PRE-OP TIGHTNESS TEST. THE T1 HAS THE FOLLOWING TEST RESULTS: PRE OP TESTS: TIGHTNESS TEST - FAIL SERVICE SOFTWARE PRESSSURE CALIBRATION - VERY LOW GAIN OF 862 = 50MBAR. AT 1000 GAIN, PRESSURE IS 46.4MBAR. LEFT GAIN AT 862. EXPIRATORY VALVE CALIBRATION - TE231001 DISPLAYED ON SCREEN, VOFFSET -389 (PASSED). BINARY VALVE COMPONENT TEST - TE231001 DISPLAYED ON SCREEN, PASSED. AUTOZERO NOTOK - PVENTCONTROL 17.8<18MBAR EXPIRATORY VALVE COMPOENT TEST - PEXPVALVE NOTOK (PRESSURE 30.5 (26.2-27.2)). TE231001 DISPLAYED ON SCREEN. PRESSURE NOTOK (PRESSURE 44.1 (47.0-53.0)). TE231001 DISPLAYED ON SCREEN. PROX TEST - DURING PROX PRESSURE 231001 DISPLAYED ON SCREEN, PASSED. CHECK VALVE - TEST JUST KEEPS RUNNING AND NEVER COMPLETES. IF THE TEST LUNG IS SQUEEZED TO INCREASE PRESSURE, TEST PASSES. PRESSURE SYSTEM TEST - PRESSURES ARE LOW. TIGHTNESS TEST - NOTOK AFTER OBSTRUCTION VALVE CLOSES PRESSURE TOO LOW (38.9 (MIN 43.0).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824946 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown