BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 18299340 · Received December 11, 2023

    Report

    Report Number
    3001421318-2023-04126
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 8, 2023
    Report Date
    August 5, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813532
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE REPEATEDLY ALARMED FOR LOSS OF EXTERNAL POWER AND SWITCHES BETWEEN AC AND DC WHEN CONNECTED TO MAINS. - THE MOMENT WHEN THIS EVENT HAPPENED OR WHEN IT WAS NOTICED HAS NOT BEEN REPORTED TO HAMILTON. THE LOSS-OF-EXTERNAL-POWER TEST IS ALSO PART OF THE PREOPERATIONAL CHECK. - THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 244001 (EXTERNALPOWERLOSS). - THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON AS VENTILATOR DEVICE REPEATEDLY ALARMED FOR LOSS OF EXTERNAL POWER AND SWITCHES BETWEEN AC AND DC WHEN CONNECTED TO MAINS. THE MOMENT WHEN THIS EVENT HAPPENED OR WHEN IT WAS NOTICED HAS NOT BEEN REPORTED TO HAMILTON. THE LOSS-OF-EXTERNAL-POWER TEST IS ALSO PART OF THE PREOPERATIONAL CHECK. THE ALARM WAS OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TE 244001 (EXTERNALPOWERLOSS). THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845608 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 1610060 07630002813532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown