BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19413579 · Received May 29, 2024

    Report

    Report Number
    3001421318-2024-01329
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 17, 2024
    Report Date
    October 21, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, BATTERY FROM VENTILATOR DEVICE SOMETIMES FAILS TO CHARGE. - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. HAMILTON MEDICAL AG HAS NOT RECEIVED ANY FURTHER EXPLANATION OR INFORMATION ABOUT THIS. - WHETHER ANY ALARMS WERE TRIGGERED WAS NOT REPORTED, BUT THE LOGS SAY OTHERWISE. - THE INSTRUMENT REPORT AND THE DEVICE LOG FILE'S (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG AND SHOWN THAT THE DEVICE INTERMITTENTLY ALARMED FOR "LOSS OF EXTERNAL POWER" AND THERE WAS NO INDICATION OF AC MAINS WHEN CONNECTED TO MAINS. - THERE IS PATIENT INVOLVEMENT REPORTED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION BUT WAS NOT FURTHER SPECIFIED NOR EXPLAINED. - 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 MEDICAL AG AS, BATTERY FROM VENTILATOR DEVICE SOMETIMES FAILS TO CHARGE. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. HAMILTON MEDICAL AG HAS NOT RECEIVED ANY FURTHER EXPLANATION OR INFORMATION ABOUT THIS. WHETHER ANY ALARMS WERE TRIGGERED WAS NOT REPORTED, BUT THE LOGS SAY OTHERWISE. THE INSTRUMENT REPORT AND THE DEVICE LOG FILE'S (SERVICE LOG, ERROR LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG AND SHOWN THAT THE DEVICE INTERMITTENTLY ALARMED FOR "LOSS OF EXTERNAL POWER" AND THERE WAS NO INDICATION OF AC MAINS WHEN CONNECTED TO MAINS. THERE IS PATIENT INVOLVEMENT REPORTED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION BUT WAS NOT FURTHER SPECIFIED NOR EXPLAINED. 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
    1825959 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown