BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-H900

    MDR report key: 16596469 · Received March 23, 2023

    Report

    Report Number
    3001421318-2023-00855
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 8, 2023
    Report Date
    April 9, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BTT
    PMA / PMN Number
    K163283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG 1 YEAR AGO, NO ATTEMPT WILL BE MADE TO OBTAIN ADDITIONAL INFORMATION. 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 IN USE. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE WATER CHAMBER. THE BREATHING CIRCUIT SET (INCL. WATER CHAMBER) WAS REPLACED TO SOLVE THE ISSUE. THERE WAS NO PATIENT OR USER HARM. REGARDING THE "LEAKY CHAMBER" CASES, ECOM-2665 HAS BEEN INITIATED AND COMPLETED TO DEVELOP AND IMPLEMENT THE REQUIRED IMPROVEMENTS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION FROM THE DISTRIBUTOR:"ON NICU IN FORDE WHEN SETTING UP THE DEVICE, THE CHAMBER COULD NOT BE FILLED WITH WATER, INSTEAD THE CHAMBER WAS LEAKING AT THE CONNECTION OF THE WATER-FEEDING-LINE. THEY OTRIED SEVERAL CIRCUITS WITH BATCH NUMBER (B)(4): BUT ALL SHOWED THE SAME PROBLEM. THERAPY COULD NOT BE STARTED, NURSE HAD TO RUN TO THE ADULT ICU AND GET A NEO CIRCUIT 260185 FROM THEM WITH REV 7, THIS FINALLY THEY GOT TO WORK"

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION FROM THE DISTRIBUTOR:"ON NICU IN (B)(6) WHEN SETTING UP THE DEVICE, THE CHAMBER COULD NOT BE FILLED WITH WATER, INSTEAD THE CHAMBER WAS LEAKING AT THE CONNECTION OF THE WATER-FEEDING-LINE. THEY TRIED SEVERAL CIRCUITS WITH BATCH NUMBER 1900078317: BUT ALL SHOWED THE SAME PROBLEM. THERAPY COULD NOT BE STARTED, NURSE HAD TO RUN TO THE ADULT ICU AND GET A NEO CIRCUIT 260185 FROM THEM WITH REV 7, THIS FINALLY THEY GOT TO WORK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479922 HAMILTON-H900 H900 HUMIDIFIER BTT HAMILTON MEDICAL AG HAMILTON-H900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown