BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18695545 · Received February 13, 2024

    Report

    Report Number
    3001421318-2023-10823
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    August 30, 2022
    Report Date
    February 12, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    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: WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. THE ROOT CAUSE OF THE VENTILATOR WAS A DEFECTIVE EXPIRATION VALVE AND CHECK VALVE ASSEMBLY. THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. 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.

    Description of Event or Problem · 0

    TIGHTNESS TEST WAS WOULD NOT PASS, I COULD HEAR THE LEAK, TRIED ANOTHER EXPIRATORY VALVE AND STILL THE LEAK, REPLACED EXPIRATORY VALVE ASSEMBLY AND LEAK IS GONE, TIGHTNESS PASSES. SERVICE SOFTWARE AND FUNCTION CHECK PASS. FROM:161265:01:H15440121 TO MSP161265:01:H22160049. RELEASE VALVE DEFECTIVE WAS SHOWING ON THE VENT, IT DID GO AWAY WHEN EXPIATORY VALVE WAS REPLACED BUT THE CHECK VALVE DID FAIL DURING TESTING SO I THOUGHT IT BEST TO REPLACE IT. ONCE REPLACED NO ISSUES. SERVICE SOFTWARE AND FUNCTION CHECK ALL PASS. FROM:161192:00:1536 TO MSP161192:04:2031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137057 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown