BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16331249 · Received February 9, 2023

    Report

    Report Number
    3001421318-2023-00107
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    November 16, 2019
    Report Date
    June 2, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813549
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: THE ISSUE IN CER (B)(4) IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION 'WHITE/ DISTRURBED SCREEN ' WHICH LOGS DIFFERENT TFS ON THE NEXT START-UP, CAUSES THE VENTILATOR TO BECOME INOPERABLE OR STOP WORKING AS INTENDED. THE ROOT CAUSE OF THE VENTILATOR TO STOP VENTILATION AND SHOWING A WHITE/ DISTURBED SCREEN WAS A MALFUNCTION OF THE FPGA ON THE 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 WAS NO PATIENT OR USER HARM REPORTED AT ALL FROM COMPLAINANT WHICH SHOULD HAVE LED TO FURTHER QUESTIONS REGARDING ANY HARM TO THE PATIENT OR USER. AS THE COMPLAINT CER (B)(4) WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. THE ALLEGATION IN CER (B)(4) 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 THE ISSUE IN CER (B)(4) AS IT WILL BE DEEMED A REPORTABLE EVENT.

    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 BY HAMILTON MEDICAL INC. UF/IMPORTER REPORT #: (B)(4). USER REPORTED THE DEVICE PRODUCED ALARMS, SCREEN WENT "BLANK", AND DISCONTINUED ACTIVE VENTILATION. NO PATIENT HARM REPORTED. DURING VENTILATION, THE DEVICE ALARMS WITH TF431001 (BLOWER FAULT) AND TF446029 (AMBIENT FAILURE DETECTED) AND ENTERS AMBIENT MODE ("VENTILATION CANCELED" LOGGED AS TF485001). THE ISSUE MAY CAUSE THE VENTILATOR TO BECOME INOPERABLE OR STOP WORKING AS INTENDED. IN THIS ISSUE THE SCREEN GOT BLACK AND THE VENTILATION STOPPED. NO HARM TO PATIENT OR USER. 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 FIND OUT THE DEFINITE ROOT CAUSE.

    Description of Event or Problem · 0

    DURING VENTILATION, THE DEVICE ALARMS WITH TF431001 (BLOWER FAULT) AND TF446029 (AMBIENT FAILURE DETECTED) AND ENTERS AMBIENT MODE ("VENTILATION CANCELED" LOGGED AS TF485001).

    Description of Event or Problem · 0

    DURING VENTILATION, THE DEVICE ALARMS WITH TF431001 (BLOWER FAULT) AND TF446029 (AMBIENT FAILURE DETECTED) AND ENTERS AMBIENT MODE ("VENTILATION CANCELED" LOGGED AS TF485001).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411530 HAMILTON MEDICAL AG HAMILTON-T1 CBK HAMILTON MEDICAL AG HAMILTON-T1 07630002813549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown