BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17683657 · Received September 5, 2023

    Report

    Report Number
    3001421318-2023-20451
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 29, 2021
    Report Date
    September 4, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    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

    SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN 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 WAS DETERMINED TO BE A COMMUNICATION FAILURE BETWEEN VU ESM BOARD AND IP ESM BOARD. IN CONSEQUENCE (CORRECTION) THE VU ESM BOARD AND IP ESM BOARD WERE REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    HELLO, BELOW IS THE TEXT FROM EMAILS FROM THE RT AND BIOMED AT UF SHANDS WITH "PANEL DISCONNECT" . WILL BE ONSITE TO REPLACE VU & IP ESM'S ASAP. ---"THIS IS VENT THAT CRASHED ON PT. I ATTACHED EVENT LOGS. RT SAID CONTROL PANEL DISCONNECT ON PATIENT. NO HARM TO PATIENT. VENT WILL NOT TURN OFF. (SIGMA#139043 OUR ASSET NUMBER). THIS HAPPENED AT (B)(6) 2021 AT 3AM. BELOW IS RT JUSTIN GILMORES NOTES. WHEN I BOOTED IT UP THIS MORNING, IT BOOTED UP AS IF IT WAS STILL RUNNING ON PATIENT. I PLACED INTO STANDBY MODE AND FOUND PANEL DISCONNECT, BUT ALSO MANY LOSS OF AIR AND O2 ALARMS AND TIME AND DATE WAS WRONG. EVERYTHING POINTED TO A LOSS OF COMMUNICATION BETWEEN UI AND BDU. BATTERY WAS EMPTY, BUT THAT WAS PROBABLY THEM UNPLUGGING VENT TO STOP ALARMING. VENT RECORDED PANEL DISCONNECT AT (B)(6) 2021 AT 9AM, BUT LOGS THEN SKIP FROM (B)(6) 2021, TO (B)(6) 2021 THEN TO (B)(6)2020 ON A BRAND NEW VENTILATOR. HEY, I JUST WANTED TO GIVE YOU GUYS A HEADS UP ON A HAMILTON G5 THAT WE HAD ATTACHED TO A PATIENT IN UA4222. AT 300 AM THE THERAPIST NOTICED THE VENT ALARMING. ONCE SHE WENT INTO THE ROOM SHE NOTICE IT SAID PANEL CONNECTION LOST . THE VENT WAS NOT VENTILATING THE PATIENT SO SHE UN-HOOKED PATIENT AND STARTED BAGGING. NO HARM WAS DONE TO THE PATIENT. WE DID PLACE A PSR ON THE VENT. I ALSO PLACED A WORK ORDER IN AND PLACED IT IN COLINS OFFICE WITH THE BROKEN EQUIPMENT FORM ON IT. SIGMA #139043. LET ME KNOW IF THERE IS ANYTHING I CAN DO TO HELP. THANKS (B)(6)"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639434 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown