BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16416746 · Received February 22, 2023

    Report

    Report Number
    3001421318-2023-00282
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    April 26, 2021
    Report Date
    September 26, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K121225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.  REPORTED BY USER OUTSIDE THE US. REPORT REFERENCE 127420900202100028. 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 MADE TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. 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 PREPARED FOR TREATMENT. ANOTHER DEVICE WAS MADE AVAILABLE, BUT THE PATIENT EXPERIENCED POTENTIAL DESATURATION IN THE MEANTIME. THE MOST PROBABLE ROOT CAUSE WAS A LOOSE CONNECTION OF THE WIRING CABLE BETWEEN SENSOR BOARD AND MAIN BOARD POTENTIALLY DUE TO THE AGING OF THE DEVICE AND/ OR GAP IN MAINTENANCE. AFTER RECONNECTION OF THE WIRE THE DEVICE PASSED THE SELF-TEST, AND THE ISSUE WAS RESOLVED. THE COMPLAINT IS REPORTABLE.

    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 USER OUTSIDE THE US. REPORT REFERENCE (B)(4). THE REPORT FROM HOSPITAL SAYS: "THE VENTILATOR WAS BEING PREPARED FOR THE EMERGENCY PATIENT. THE MACHINE COULD NOT PASS SELF-TEST AFTER STARTUP AND REPORTED AN ERROR. IT DELAYED THE TREATMENT TIME AND THE PATIENT'S SPO2 KEPT DROPPING. HAMILTON-C2 MADE IN 2012. A BACKUP MACHINE WAS USED, AND MAINTENANCE REQUEST WAS ORDERED." AFTER INVESTIGATION, THE SITUATION IN THE REPORT IS TRUE. THE MACHINE FAILED TO PASS SELF-TEST AND COULD NOT BE STARTED UP. ENGINEER REN TIANYI FROM THE EQUIPMENT DEPARTMENT CHECKED THE MACHINE AND FOUND THAT THE CONNECTING WIRE BETWEEN THE MAINBOARD AND THE SENSOR BOARD WAS LOOSE. AFTER RECONNECTION, THE MACHINE PASSED SELF-TEST AND WORKED NORMALLY. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT IS LIKELY TO CAUSE SERIOUS INJURY OR DEATH TO PATIENT IF IT WERE TO REOCCUR.

    Description of Event or Problem · 0

    THE VENTILATOR WAS BEING PREPARED FOR THE EMERGENCY PATIENT. THE MACHINE COULD NOT PASS SELF-TEST AFTER STARTUP AND REPORTED AN ERROR. IT DELAYED THE TREATMENT TIME AND THE PATIENT'S SPO2 KEPT DROPPING. HAMILTON-C2 MADE IN 2012.

    Description of Event or Problem · 0

    THE VENTILATOR WAS BEING PREPARED FOR THE EMERGENCY PATIENT. THE MACHINE COULD NOT PASS SELF-TEST AFTER STARTUP AND REPORTED AN ERROR. IT DELAYED THE TREATMENT TIME AND THE PATIENT'S SPO2 KEPT DROPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642757 HAMILTON MEDICAL AG HAMILTON-C2 CBK HAMILTON MEDICAL AG HAMILTON-C2 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention