BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18872093 · Received March 10, 2024

    Report

    Report Number
    3001421318-2023-40715
    Event Type
    Malfunction
    Date Received
    March 10, 2024
    Date of Event
    February 3, 2023
    Report Date
    March 9, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: 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 TESTED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE IR SENSOR. IN CONSEQUENCE THE SENSOR BOARD WAS REPLACED. THERE WAS NO REPORTED PATIENT OR USER HARM. (NO PATIENT INVOLVEMENT).

    Description of Event or Problem · 0

    DURING TESTING H900 WOULD SHOW CONSTANT HIGH WATER LEVEL ALARM; EVEN THOUGH THE WATER LEVEL WAS LESS THAN MAX LEVEL. REPLACEMENT OF THE SENSOR BOARD RESOLVED THE ISSUE. SERVICE SOFTWARE AND FUNCTION CHECKS ALL PASS. FROM: 950456: 05: 22238 TO MSP950457: 06: 40219.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695328 HAMILTON MEDICAL AG HAMILTON-H900 CBK HAMILTON MEDICAL AG HAMILTON-H900 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown