BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16320037 · Received February 8, 2023

    Report

    Report Number
    3001421318-2023-00073
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    March 5, 2020
    Report Date
    July 7, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    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(B)(6)2022 AT THE EMS AND BONADUZ SITES.  "VENTILATOR UNIT CONNECTION LOST". UNKNOWN IF THE EVENT OCCURRED DURING VENTILATION. NO HARM TO PATIENT OR USER.DURING VENTILATION THE SCREEN BECAME BLACK THE ( THE UNIT CONTINUED TO VENTILATE). NO HARM TO PATIENT OR USER. THE ISSUE IS DEEMED AS A REPORTABLE EVENT SINCE THE DEIVCE CANNOT BE OPERATED BY THE MEDICAL STAFF. IF THE FAILURE 'VENTILATOR UNIT CONNECTION LOST' OCCURRED AFTER STARTING UP THE VENTILATOR MAY LEAD TO A DELAY OF THE PROCEDURE AS THE PROCEDURE MUST BE RE-PLANNED OR COMPLETED USING AN ALTERNATIVE MEANS OF VENTILATION. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT IS LIKELY TO CAUSE SERIOUS INJURY OR DEATH. NEITHER IS THE ISSUE LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT IS LIKELY TO CAUSE SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. AN INVESTIGATION FOR THIS CASE IS ONGOING IN ORDER TO CONFIRM THE ROOT CAUSE.

    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 ALMOST 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED 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 VENTILATOR WAS USED. THE ROOT CAUSE OF THE "VENTILATOR UNIT CONNECTION LOST" COULD NOT BE DETERMINED AS THE FAILURE WAS NOT REPRODUCIBLE AND UNTIL TODAY (04.07.2023) THE CUSTOMER DID NOT REPORT RECURRENCE OF THE EVENT. NO CORRECTIONS HAVE BEEN MADE. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    NORTHSIDE ATLANTA REPORTED SN (B)(4) IPP SHUTOFF AND WOULD NOT COME BACK ON UNTIL POWERED DOWN. THIS EVENT WAS REPORTED TO ME ON 3/16. TF (B)(4) OCCURRED ON 3/5, THOUGH THERE ARE NO OTHER TF'S THAT POINT TO AN ISSUE WITH SCREEN CONNECTION/BLACKOUT.

    Description of Event or Problem · 0

    NORTHSIDE ATLANTA REPORTED G5 (B)(6). IPP SHUTOFF AND WOULD NOT COME BACK ON UNTIL POWERED DOWN. THIS EVENT WAS REPORTED TO ME ON 3/16. TF 5024 OCCURRED ON 3/5, THOUGH THERE ARE NO OTHER TF'S THAT POINT TO AN ISSUE WITH SCREEN CONNECTION/BLACKOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211751 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown