BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17736158 · Received September 13, 2023

    Report

    Report Number
    3001421318-2023-21055
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    July 16, 2021
    Report Date
    September 12, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, (B)(4) HAS BEEN INITIATED AND COMPLETED TO DEVELOP AND IMPLEMENT THE REQUIRED IMPROVEMENTS.

    Description of Event or Problem · 0

    SINCE THE PHENOMENON OF WATER LEAKAGE OCCURRED FREQUENTLY, THE HOSPITAL STAFF UNPACKED A SEPARATE LOT BREATHING CIRCUIT SET. (LOT.1052840) HOWEVER, WATER LEAKAGE OCCURRED FROM THE ROOT OF THE WATER SUPPLY TUBE WHEN THE CUSTOMER WAS USING IT. WE HAVE RECEIVED STRONG COMPLAINTS FROM CUSTOMERS THAT THERE ARE TOO MANY DEFECTIVE PRODUCTS. PLEASE LET ME KNOW WHEN THE PERMANENT COUNTERMEASURE CIRCUIT SETS WILL BE SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89027 HAMILTON MEDICAL AG HAMILTON-H900 CBK HAMILTON MEDICAL AG HAMILTON-H900 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown