BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17048772 · Received June 2, 2023

    Report

    Report Number
    3001421318-2023-02050
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 1, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A CASE REPORT RECEIVED ON 15TH MAY 2023 FROM DEVICE TECHNOLOGIES AUSTRALIA, REGARDING AN EVENT INVOLVING A HAMILTON-T1 (B)(4) THAT OCCURRED ON SEPTEMBER 12TH 2022 AT CHILDRENS HEALTH QUEENSLAND. ACCORDING TO THE REPORT, THE FOLLOWING WAS OBSEREVED DURING PRE-OPERATIONAL CHECK. [1] ORIGINAL COMPLAIN WAS TIGHTNESS FAILURE. [2] TIGHTNESS TEST, EXP VALVE TEST AND CHECK VALVE TEST FAILED. PRESSURE TEST OF EXP VALVE(LEAKAGE) IS OUT OF THE TOLERANCE, TEST FAILED. OBSTRUCTION VALVE ACTIVATION TEST FAILED UNDER CHECK VALVE TEST. [3] AUTOZERO FAIL DURING FLOW SENSOR CALIBRATION, EXPIRATORY VALVE PRESSURE TEST. THE FOLLOWING CORRECTION WAS DONE: [1] CONTROL BOARD REPLACED. [2] PRESSURE SENSOR ASSEMBLY REPLACED. [3] SOFTWARE UPGRADED TO 2.2.10. NO PATIENT INVOLVED. NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT AND OPERATOR. ACCORDING TO THE PRELIMINARY ANALYSIS: THE LOG FILE SHOWS THE FOLLOWING FAILURES: 2022-12-05 08:14:15/TEST /OBSTRUCTION VALVE TEST FAILED 2022-12-05 07:35:57/TEST /SYS TUBING TIGHTNESS TEST FAILED 2022-12-02 07:18:08/TEST /NEO EXHALATION PRESSURE TEST FAILED 2022-12-01 14:54:18/TEST /PROXIMAL PRESSURE TEST FAILED 2022-12-01 14:44:02/TEST /BLOWER FLOW TEST FAILED 2022-09-18 10:25:39/TEST /TIGHTNESS TEST FAILED FOLLOWING TFS AND TES APPEARED IN LOGS DURING REPAIR. 433002 TFABPG_CONTROLTICKTIMINGERROR 481003 TFASTU_UNKNOWNPARTNUMBER 481004 TFASTU_TECHNICALSTATEERROR 431002 TFAGD_BLOWERDISCONNECTED 246006 TALLS_EEPROMDEFAULTS 231001 TAGD_PRESSURECONTROLLERPRESSURELOW REALTIME CLOCK FAILURE POTENTIEL ROOT CAUSE IDENTIFIED ARE AS FOLLOW: LEAK ( INSPIRATION PATH / BREATHING CIRCUIT) UNTIGHT MEMBRANE LEAKY / DEFECTIVE PROPORTIONAL VALVE LEAK IN FLOW SENSOR AIR (QVENT).

    Description of Event or Problem · 0

    THIS IS A CASE REPORT RECEIVED ON 15TH MAY 2023 FROM DEVICE TECHNOLOGIES AUSTRALIA, REGARDING AN EVENT INVOLVING A HAMILTON-T1 (B)(4) THAT OCCURRED ON SEPTEMBER 12TH 2022 AT CHILDRENS HEALTH QUEENSLAND. ACCORDING TO THE REPORT, THE FOLLOWING WAS OBSEREVED DURING PRE-OPERATIONAL CHECK. [1] ORIGINAL COMPLAIN WAS TIGHTNESS FAILURE. [2] TIGHTNESS TEST, EXP VALVE TEST AND CHECK VALVE TEST FAILED. PRESSURE TEST OF EXP.VALVE(LEAKAGE) IS OUT OF THE TOLERANCE, TEST FAILED. OBSTRUCTION VALVE ACTIVATION TEST FAILED UNDER CHECK VALVE TEST. [3] AUTOZERO FAIL DURING FLOW SENSOR CALIBRATION, EXPIRATORY VALVE PRESSURE TEST. THE FOLLOWING CORRECTION WAS DONE: [1] CONTROL BOARD REPLACED. [2] PRESSURE SENSOR ASSEMBLY REPLACED. [3] SOFTWARE UPGRADED TO 2.2.10. NO PATIENT INVOLVED. NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT AND OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509112 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown