BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-H900

    MDR report key: 16434028 · Received February 24, 2023

    Report

    Report Number
    3001421318-2023-00346
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    February 9, 2023
    Report Date
    April 3, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BTT
    PMA / PMN Number
    K163283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DISCOVERED THAT SOME OF THE REPORTED EVENTS HAPPENED DURING THE VENTILATION OF A PATIENT. BASED ON THE CUSTOMER'S STATEMENT THAT DURING VENTILATION, TF10 HAD OCCURRED AT 6 DIFFERENT HAMILTON-H900, AFTER REPLACEMENT OF THE TUBE SETS THIS ERROR MESSAGE DISAPPEARED ON ALL 6 HAMILTON-H900. TF 10 IS CALLED "TUBE FUSE ERROR" MEANS THE FUSES OF THE HEATING FOR THE BREATHING CIRCUIT ARE BLOWN CAUSED BY A SHORT CUT BETWEEN THE WIRES INSIDE THE BREATHING CIRCUIT. SINCE WE DID NOT RECEIVE THE EFFECTED BREATHING CIRCUIT SETS, ANALYSIS COULD NOT BE PERFORMED. ACCORDING TO OUR KNOWLEDGE FROM PAST FAILURE ANALYSES, THE POSSIBLE CAUSE THAT CAN LEAD TO A TF 10 IS A SHORT CIRCUIT BETWEEN PIN 3 AND PIN 4.

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE HUMIDIFIER WAS USED ON A PATIENT (THE HUMIDIFIER WAS THEN NOT WORKING). THE ROOT CAUSE COULD NOT BE DETERMINED BUT HUMIDITY IN THE DEVICE (DUE TO THE USAGE) MAY HAVE HAD AN IMPACT. NO CORRECTION NEEDED TO BE PERFORMED WHEN THE DEVICE WAS CHECKED. THERE WAS NO REPORTED PATIENT OR USER HARM.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REQUESTED FURTHER INFORMATION FROM THE HOSPITAL REGARDING THE NUMBER OF THE PATIENT(S ) INVOLVED AND THE OCCURRENCE OF INCIDENT. WE HAVEN`T RECEIVED FEEDBACK YET. TECHNICAL FAULT 10 INDICATES A DEFECTIVE (SHORT CIRCUIT) BREATHING CIRCUIT. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION:"THE TF 10 TUBE FUSE ERROR OCCURRED DURING VENTILATION ON SIX H900S IN COMBINATION WITH THE LEONI PLUS. DURING THE TEST, NO FAULT COULD BE FOUND IN THE H900 REF OF HOSE SYSTEMS (B)(4). "

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION:"THE TF 10 TUBE FUSE ERROR OCCURRED DURING VENTILATION ON SIX H900S IN COMBINATION WITH THE LEONI PLUS.DURING THE TEST, NO FAULT COULD BE FOUND IN THE H900REF OF HOSE SYSTEMS 260185"

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION:"THE TF 10 TUBE FUSE ERROR OCCURRED DURING VENTILATION ON SIX H900S IN COMBINATION WITH THE LEONI PLUS. DURING THE TEST, NO FAULT COULD BE FOUND IN THE H900 REF OF HOSE SYSTEMS 260185"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059040 HAMILTON-H900 H900 HUMIDIFIER BTT HAMILTON MEDICAL AG HAMILTON-H900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown