BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16362530 · Received February 13, 2023

    Report

    Report Number
    3001421318-2023-00181
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    September 4, 2020
    Report Date
    February 14, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201306
    Adverse Event
    Yes
    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.  THE ISSUE IN (B)(4) IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION 'VENTILATION STOPPED ON PATIENT' WHICH CAUSES THE DEVICE TO SWITCH TO AMBIENT STATE DURING VENTILATION WILL CAUSE THE VENTILATOR TO BECOME INOPERABLE OR STOP WORKING AS INTENDED. THE ROOT CAUSE OF THE VENTILATOR DEVICE IS ASSUMED TO BE A DEFECTIVE VU ESM BOARD. A DETAILED INVESTIGATION WAS NOT POSSIBLE BECAUSE THE CUSTOMER DID NOT RETURN THE DEFECTIVE ESM BOARD. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE IT WAS USED FOR TREATMENT OR DIAGNOSIS. THERE ARE CONFLICTING PIECES OF INFORMATION IN THE COMPLAINT DATABASE. ON THE ONE HAND, IT IS STATED IN THE "ADDITIONAL EVENT INFORMATION" SECTION THAT NO PATIENT, USER OR THIRD PARTY WAS HARMED. ON THE OTHER HAND, IN THE COMPLAINT / FAILURE INFORMATION SECTION IT IS STATED THAT THE DEVICE FAILURE "CAUSED ADDITIONAL TREATMENT TO BE NECESSARY". HAMILTON MEDICAL AG AND HAMILTON MEDICAL INC. TRIED SEVERAL TIMES OVER A PERIOD OF ALMOST ONE YEAR TO CONTACT THE CUSTOMER (CENTRAL VERMONT MEDICAL CENTER) AND FIND OUT MORE ABOUT WHAT HAPPENED. THE CUSTOMER DID NOT REPLY. AS THE COMPLAINT (B)(4) WAS SUBMITTED TO HAMILTON MEDICAL AG OVER 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED ANYMORE TO OBTAIN ADDITIONAL INFORMATION. THE ALLEGATION IN (B)(4) WAS CONFIRMED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE.

    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.  REPORTED TO FDA BY USER. REPORT ADDED IN FILE.IT WAS REPORTED BY COMPLAINANT "CUSTOMER CALLED AND TOLD ME VENT STOPPED ON A PATIENT AND HAD RED AND GREEN BUTTONS ON SCREEN LIT. ASKED THEM TO SEND ME LOGS AND I'D TAKE A LOOK, LOOKS LIKE VENT LOST ALL POWER AND SHUT DOWN. ACCORDING TO THE SERVICE REPORT THIS DEVICE HAS NOT BEEN PM/SERVICE SOFTWARE TESTING SINCE LATE 2016." THE ISSUE CAUSED ADDITIONAL TREATMENT TO BE NECESSARY. THE ISSUE IN CER 83607 IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION 'VENTILATION STOPPED ON PATIENT' WHICH CAUSES THE DEVICE TO SWITCH TO AMBIENT STATE DURING VENTILATION WILL CAUSE THE VENTILATOR TO BECOME INOPERABLE OR STOP WORKING AS INTENDED. THE ROOT CAUSE OF THE VENTILATOR DEVICE IS ASSUMED TO BE A DEFECTIVE VU ESM BOARD. A DETAILED INVESTIGATION WAS NOT POSSIBLE BECAUSE THE CUSTOMER DID NOT RETURN THE DEFECTIVE ESM BOARD. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE IT WAS USED FOR TREATMENT OR DIAGNOSIS. THERE ARE CONFLICTING PIECES OF INFORMATION IN THE COMPLAINT DATABASE. ON THE ONE HAND, IT IS STATED IN THE "ADDITIONAL EVENT INFORMATION" SECTION THAT NO PATIENT, USER OR THIRD PARTY WAS HARMED. ON THE OTHER HAND, IN THE COMPLAINT / FAILURE INFORMATION SECTION IT IS STATED THAT THE DEVICE FAILURE "CAUSED ADDITIONAL TREATMENT TO BE NECESSARY". HAMILTON MEDICAL AG AND HAMILTON MEDICAL INC. TRIED SEVERAL TIMES OVER A PERIOD OF ALMOST ONE YEAR TO CONTACT THE CUSTOMER (CENTRAL VERMONT MEDICAL CENTER) AND FIND OUT MORE ABOUT WHAT HAPPENED. THE CUSTOMER DID NOT REPLY. AS THE COMPLAINT CER 83607 WAS SUBMITTED TO HAMILTON MEDICAL AG OVER 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED ANYMORE TO OBTAIN ADDITIONAL INFORMATION. THE ALLEGATION IN CER 83607 WAS CONFIRMED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE.

    Description of Event or Problem · 0

    CUSTOMER CALLED AND TOLD ME VENT STOPPED ON A PATIENT AND HAD RED AND GREEN BUTTONS ON SCREEN LIT. ASKED THEM TO SEND ME LOGS AND I'D TAKE A LOOK, LOOKS LIKE VENT LOST ALL POWER AND SHUT DOWN.

    Description of Event or Problem · 0

    CUSTOMER CALLED AND TOLD ME VENT STOPPED ON A PATIENT AND HAD RED AND GREEN BUTTONS ON SCREEN LIT. ASKED THEM TO SEND ME LOGS AND I'D TAKE A LOOK, LOOKS LIKE VENT LOST ALL POWER AND SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516382 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention