BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16563606 · Received March 17, 2023

    Report

    Report Number
    3001421318-2023-00730
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    April 3, 2022
    Report Date
    September 14, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K121225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.  DETAILED COMPLAINT AND FAILURE DESCRIPTION: "TECHNICAL EVENT 231009 OCCURRED AND THEN VENTILATION STOPPED. MEDICAL INTERVENTION REQUIRED: USER STOPPED THERAPY DUE TO THE APPEARANCE OF TECH EVENT 231009" DEVICE ALARMS WITH HIGH PRIORITY TECHNICAL EVENT: 231009 (ALARM BLOWER SPEED LOW). 231009 (ALARM BLOWER SPEED LOW). DEFECTIVE BLOWER. THERAPY STOPPED BY USER SINCE VENTILATION STOPPED. NO HARM TO PATIENT OR USER. THE ISSUE MAY LEAD TO INSUFFICIENT VENTILATION OR 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 IF IT WERE TO RECUR.

    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: THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE TECHNICAL EVENT COULD LEAD TO A DELAY IN THE THERAPY, SINCE THE VENTILATOR CANNOT BE USED. A FUNCTIONAL VENTILATOR NEEDS TO BE PREPARED. THE ROOT CAUSE OF THE VENTILATOR TO ALARM WITH TE 231009 ALARM WAS A MALFUNCTION OF THE BLOWER. THE CORRECTION IN THIS CASE AND THE SIMILAR CASES WOULD HAVE BEEN THE REPLACEMENT OF THE DEFECTIVE COMPONENT (BLOWER MODULE). WITHIN 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 TO BE USED FOR TREATMENT OR DIAGNOSIS. THERE WAS NO PATIENT, USER OR THIRD-PARTY HARM. THE ALLEGATION IN THIS COMPLAINT IS ASSUMED TO BE A COMPLAINT, BASED ON THE EXPERIENCE HM HAS GATHERED BY INVESTIGATING OTHER COMPLAINTS WITH THE SAME FAILURE MODE AND FAILURE EFFECT. 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.

    Description of Event or Problem · 0

    TECHNICAL EVENT: 231009 DUE TO DEFECTIVE BLOWER.

    Description of Event or Problem · 0

    TECHNICAL EVENT: 231009 DUE TO DEFECTIVE BLOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559004 HAMILTON MEDICAL AG HAMILTON-C2 CBK HAMILTON MEDICAL AG HAMILTON-C2 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown