BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18845177 · Received March 6, 2024

    Report

    Report Number
    3001421318-2023-42214
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    November 21, 2022
    Report Date
    March 5, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 VENTILATOR WAS TESTED. THE ROOT CAUSE WAS DETERMINED TO BE A PARTLY DISCONNECTION ON THE CABLE CONNECTING THE VU MOTHERBOARD AND SERVO BOARD WHICH IS LOCATED ON THE INSPIRATORY VALVE ASSEMBLY. IN CONSEQUENCE (CORRECTION) THE CABLE FROM THE VU MOTHERBOARD TO THE SERVO BOARD AND SENSOR BOARD WAS REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    DEAR MILAD, A CUSTOMER CLAIM THAT THIS UNIT PASSED ALL THE TESTS. DURING A RUN ON AN ARTEFICIAL LUNG, IT STOPPED TAKE OUT AN AIR FROM THE INSP. VALVE. IT ALERTED ON:LOW TIDAL VOLUME,CHECK FLOW SENSOR AND CHECK FLOW SENSOR. THE GRAPH WAS FLAT. HE CHECKED ON TEST 8 THE MIXER VALVES TEST AND NO PRESSURE WAS BUILD. VISSUALY EVERYTHING SEEMS FINE (ALL THE CONNECTORS). HE REPLACED THE MIXER VALVES, BUT IT DIDN'T SOLVED THE PROBLEM. PLEASE ADVISE, B.R. ILAN OFMAN BEPEX LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119579 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown