BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 21803547 · Received April 9, 2025

    Report

    Report Number
    3001421318-2025-00492
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 25, 2025
    Report Date
    February 23, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1: INVESTIGATION OUTCOME. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. UPON REVIEW OF THE LOGFILES, THE REPORTED ISSUE COULD BE CONFIRMED. THE DEVICE ALARMED SEVERAL TIMES WITH TF5507 ON THE DAY OF THE EVENT. IT IS IMPORTANT TO EMPHASIZE THAT NO HARM TO THE PATIENT WAS REPORTED. PLEASE SEE BELOW EXTRACT FROM THE LOGFILES. 2025-03-25 11:42:25 AUDIO PAUSED ON SPECIAL 516, 2025-03-25 11:42:20 HIGH OXYGEN ALARMS 5002, 2025-03-25 11:42:09 TF : 5507 TECH FAULT 5507, 2025-03-25 11:42:02 TF : 5507 TECH FAULT 5507, 2025-03-25 11:41:56 TF : 5507 TECH FAULT 5507, 2025-03-25 11:40:36 TF : 5507 TECH FAULT 5507, 2025-03-25 11:40:18 TF : 5507 TECH FAULT 5507 2025-03-25 11:40:14 TF : 5507 TECH FAULT 5507,, 2025-03-25 11:40:08 TF : 5507 TECH FAULT 5507, 2025-03-25 11:39:48 AUDIO PAUSED OFF SPECIAL 517, 2025-03-25 11:39:48 TF : 5507 TECH FAULT 5507, 2025-03-25 11:39:33 AUDIO PAUSED ON SPECIAL 516, 2025-03-25 11:39:29 LOW TIDAL VOLUME ALARMS 4005, 2025-03-25 11:39:17 TF : 5507 TECH FAULT 5507, 2025-03-25 11:39:12 TF : 5507 TECH FAULT 5507, 2025-03-25 11:39:08 LOW MINUTE VOLUME ALARMS 5006, 2025-03-25 11:39:04 LOW TIDAL VOLUME ALARMS 4005, 2025-03-25 11:39:03 LOW MINUTE VOLUME ALARMS 5006, 2025-03-25 11:39:02 TF : 5507 TECH FAULT 5507, 2025-03-25 11:38:59 LOSS OF PEEP ALARMS 4001, 2025-03-25 11:38:58 DISCONNECTION ON PATIENT SIDE ALARMS 5010, 2025-03-25 11:38:58 LOW TIDAL VOLUME ALARMS 4005, 2025-03-25 11:38:57 AUDIO PAUSED OFF SPECIAL 517, 2025-03-25 11:38:57 TF : 5507 TECH FAULT 550. ACCORDING TO THE SERVICE MANUAL, THE TECHNICAL FAULT (TF) 5507 INDICATES THAT THE AIR OR OXYGEN INLET VALVE IS UNABLE TO CLOSE PROPERLY. BASED ON THE OBSERVED ERROR PATTERN, THE MOST PROBABLE ROOT CAUSE IS A FAILURE OR MALFUNCTION OF THE GAS CONTROL SUBSYSTEM, POTENTIALLY REQUIRING REPLACEMENT OF SENSOR BOARD . TO DATE, DESPITE SEVERAL REMINDERS, THE MANUFACTURER HAS NOT RECEIVED ANY ADDITIONAL INFORMATION OR CONFIRMATION REGARDING THE ISSUE IF IT WAS RESOLVED. CONSEQUENTLY, THE EXACT ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. HAMILTON MEDICAL CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING THE VENTILATION OF A PATIENT, THE DEVICE ALARMED SEVERAL TIMES WITH TF 5507. THE DEVICE WAS REPLACED. NO HARM TO THE PATIENT WAS REPORTED. THE MANUFACTURER WAS INFORMED THAT THE USER REPORTED THIS EVENT TO LOCAL AUTHORITIES, ALTHOUGH NO REFERENCE NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421312 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown