BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19602544 · Received June 24, 2024

    Report

    Report Number
    3001421318-2024-01508
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 23, 2024
    Report Date
    November 3, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D3, D4, G6, H2, H4, H11.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 24 MAY 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 23 MAY 2024, DURING A FLIGHT, A HAMILTON T1 VENTILATOR (SN (B)(6)) STOPPED VENTILATING AND WAS SENDING OUT ERRONEOUS NUMBERS ON THE VENILATOR. ONE OF THE MEDICS AT OUR BASE HAS PHOTOS OF THE ERROR CODE AND THE NUMBERS. NO OTHER INFORMATION AVAILABLE UP TO DATE. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LED TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON (B)(6) 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6) 2024, DURING A FLIGHT, A HAMILTON T1 VENTILATOR (SN(B)(6)) STOPPED VENTILATING AND WAS SENDING OUT ERRONEOUS NUMBERS ON THE VENILATOR. ONE OF THE MEDICS AT OUR BASE HAS PHOTOS OF THE ERROR CODE AND THE NUMBERS. NO OTHER INFORMATION AVAILABLE UP TO DATE. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LED TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115568 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown