BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19640403 · Received June 29, 2024

    Report

    Report Number
    3001421318-2024-01565
    Event Type
    Malfunction
    Date Received
    June 29, 2024
    Date of Event
    June 4, 2024
    Report Date
    November 3, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    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 07 JUNE 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 06 JUNE 2024 IN CHILDREN'S HOSPITAL OF PHILADELPHIA, PENNSYLVANIA, A HAMILTON T1 VENTILATOR ((B)(4)) SHOWED A REAL TIME CLOCK FAILURE AFTER POWER LOSS TEST DURING PREVENTIVE MAINTENANCE. ACCORDING TO THE REPORTER, WHILE COMPLETING A PM ON JUNE 4TH, 2024 THE VENTILATOR FAILED THE POWER LOSS BUZZER TEST AT APPROXIMATELY 15:20. THE BUZZER ONLY SOUNDED FOR 1 MINUTE BUT THE REAL TIME CLOCK HELD THE CORRECT DATE AND TIME. THE CONTROL BOARD WAS REPLACED AND THE POWER LOSS BUZZER TEST PASSED BUT THE REAL TIME CLOCK DID NOT HOLD THE DATE AND TIME AND LOST ALL OPTIONS. THE TIME AND DATE WERE SET AND THE TEST RUN AGAIN BUT IT FAILED AGAIN. AS IMMEDIATE CORRECTION PERFORMED, TECHNICIAN 2 ESM BOARDS AND THE DRIVER BOARD ON JUN 6TH, 2024 BUT THE PROBLEM STILL OCCURRED. ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: DEFECTIVE CONTROL BOARD (CAPACITOR). THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: REPLACE CONTROL BOARD. 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 07 JUNE 2024 . IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 06 JUNE 2024 IN (B)(6), A HAMILTON T1 VENTILATOR (SN (B)(6)) SHOWED A REAL TIME CLOCK FAILURE AFTER POWER LOSS TEST DURING PREVENTIVE MAINTENANCE. ACCORDING TO THE REPORTER, WHILE COMPLETING A PM ON JUNE 4TH, 2024 THE VENTILATOR FAILED THE POWER LOSS BUZZER TEST AT APPROXIMATELY 15:20. THE BUZZER ONLY SOUNDED FOR 1 MINUTE BUT THE REAL TIME CLOCK HELD THE CORRECT DATE AND TIME. THE CONTROL BOARD WAS REPLACED AND THE POWER LOSS BUZZER TEST PASSED BUT THE REAL TIME CLOCK DID NOT HOLD THE DATE AND TIME AND LOST ALL OPTIONS. THE TIME AND DATE WERE SET AND THE TEST RUN AGAIN BUT IT FAILED AGAIN. AS IMMEDIATE CORRECTION PERFORMED, TECHNICIAN 2 ESM BOARDS AND THE DRIVER BOARD ON JUN 6TH, 2024 BUT THE PROBLEM STILL OCCURRED. ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: DEFECTIVE CONTROL BOARD (CAPACITOR). THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: REPLACE CONTROL BOARD. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD 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
    2215026 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown