BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-H900

    MDR report key: 20863467 · Received December 6, 2024

    Report

    Report Number
    3001421318-2024-02809
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    October 29, 2024
    Report Date
    February 25, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BTT
    PMA / PMN Number
    K163283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). AT THE TIME OF COMPLETING THIS REPORT, THE SERIAL NUMBER WAS NOT AVAILABLE. CONSEQUENTLY, SECTION D4 REMAINS INCOMPLETE. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). AT THE TIME OF COMPLETING THIS REPORT, THE SERIAL NUMBER WAS NOT AVAILABLE. CONSEQUENTLY, SECTION D4 REMAINS INCOMPLETE. INVESTIGATION IS ONGOING. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE DEFECTIVE BREATHING SET WAS SENT BACK TO HAMILTON MEDICAL UNDER RGA 99594. THE INVESTIGATION SHOWED THAT THE ROOT CAUSE OF THE INCIDENT WAS A DEFECTIVE DUAL LIMB BREATHING SET (PART N° 260185). THERE WAS A LEAKAGE OF THE SWIVEL-Y PIECE. THE DUAL LIMB BREATHING SET WAS REPLACED. THERE WAS NO PATIENT OR USER HARM

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING SETUP, WHILE THE HAMILTON-H900 WAS USED, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE SWIVEL CONNECTOR IN THE CIRCUIT. INVOLVED ACCESSORIE: BREATHING CIRCUIT WITH THE SERIAL NUMBER (B)(6). NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING SETUP, WHILE THE HAMILTON-H900 WAS USED, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE SWIVEL CONNECTOR IN THE CIRCUIT. INVOLVED ACCESSORIE: BREATHING CIRCUIT WITH THE SERIAL NUMBER (B)(6). NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516639 HAMILTON-H900 HAMILTON-H900 BTT HAMILTON MEDICAL AG 260185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown