BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18845384 · Received March 6, 2024

    Report

    Report Number
    3001421318-2023-40595
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 13, 2023
    Report Date
    March 5, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. 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.

    Description of Event or Problem · 0

    LEAKY FEED SETS ON PN 260185 LOT 1900025811.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118699 HAMILTON MEDICAL AG HAMILTON-H900 CBK HAMILTON MEDICAL AG HAMILTON-H900 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown