BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON G5

    MDR report key: 21704901 · Received March 27, 2025

    Report

    Report Number
    3001421318-2025-00461
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 11, 2025
    Report Date
    September 1, 2025
    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). CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS DEVICE AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1: DEVICE EVALUATION. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE ALARMED WITH PANEL CONNECTION LOST. HOWEVER, ACCORDING TO THE LOGFILE ANALYSIS, ON THE DATE OF THE REPORTED EVENT ((B)(6) 2025), THE DEVICE GENERATED 'VENTILATOR UNIT CONNECTION LOST' ALARMS SHORTLY AFTER STARTUP AND NO PANEL CONNECTION LOST ALARMS WERE RECORDED. PLEASE REFER TO THE EXTRACT FROM THE LOGFILES BELOW. IT IS IMPORTANT TO HIGHLIGHT THAT NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT. (B)(6); 10:54:54; POWER-ON 2025-03-11; POWER; 1. 2025-03-11; 10:54:54; VENTILATOR UNIT CONNECTION LOST; ALARMS; 5024. 2025-03-11; 10:51:52; HUMIDIFIER OFF; SPECIAL; 547. 2025-03-11; 10:51:52; POWER-OFF 2025-03-11; POWER; 3. 2025-03-11; 10:51:40; INTELLICUFF MODE OFF; SPECIAL; 535. 2025-03-11; 10:51:40; INTELLICUFF MODE OFF; SPECIAL; 535. 2025-03-11; 10:51:39; OXYGEN + AIR SUPPLIES FAILED; SUPPLY; 5017. 2025-03-11; 10:51:38; AUDIO PAUSED OFF; SPECIAL; 517. 2025-03-11; 10:51:38; NEBULIZER OFF; SPECIAL; 501. 2025-03-11; 10:51:38; STANDBY ON SPECIAL; 506. 2025-03-11; 10:51:38; OPERATING TIME: 5 HOUR(S) 54 MINUTE(S); DEVICE; 825. 2025-03-11; 10:51:38; OPERATING TIME: 3397 DAY(S); DEVICE; 826. 2025-03-11; 10:51:38; POWER-ON 2025-03-11; POWER; 1. 2025-03-11; 10:51:38; VENTILATOR UNIT CONNECTION LOST; ALARMS; 5024. 2025-03-11; 10:49:30; HUMIDIFIER OFF; SPECIAL; 547. 2025-03-11; 10:49:30; POWER-OFF 2025-03-11; POWER; 3. 2025-03-11; 10:48:58; INTELLICUFF MODE OFF; SPECIAL; 535. 2025-03-11; 10:48:58; INTELLICUFF MODE OFF; SPECIAL; 535. 2025-03-11; 10:48:56; OXYGEN + AIR SUPPLIES FAILED; SUPPLY; 5017. 2025-03-11; 10:48:56; AUDIO PAUSED OFF; SPECIAL; 517. 2025-03-11; 10:48:56; NEBULIZER OFF; SPECIAL; 501. 2025-03-11; 10:48:56; STANDBY ON SPECIAL; 506. 2025-03-11; 10:48:56; OPERATING TIME: 5 HOUR(S) 53 MINUTE(S); DEVICE; 825. 2025-03-11; 10:48:56; OPERATING TIME: 3397 DAY(S); DEVICE; 826. 2025-03-11; 10:48:56; POWER-ON 2025-03-11; POWER; 1. 2025-03-11; 10:48:56; VENTILATOR UNIT CONNECTION LOST; ALARMS. THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE ESM IP, WHICH WAS SUBSEQUENTLY REPLACED. FOLLOWING THE REPLACEMENT, THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE ALARMED WITH PANEL CONNECTION LOST. HOWEVER, ACCORDING TO THE LOGFILES, VENTILATOR UNIT CONNECTION LOST ALARMS APPEARED AFTER STARTUP. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437366 HAMILTON G5 HAMILTON G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown