BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16625784 · Received March 28, 2023

    Report

    Report Number
    3001421318-2023-00959
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 2, 2023
    Report Date
    April 12, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    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 PREPARED FOR TREATMENT. THE ROOT CAUSE WAS DETERMINED TO BE A PRESUMABLY LOOSE CONNECTION OF TEMPERATURE SENSOR IN THE BLOWER MODULE. THE COMPLETE BLOWER MODULE WAS REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: FAILURE MODE DESCRIPTION: DEVICE ALARMS WITH (B)(4) (BLOWERTEMPERATURESENSORDEFECT) DURING START-UP FAILURE EFFECT: DEVICE ALARMS WITH (B)(4) (BLOWERTEMPERATURESENSORDEFECT) DURING START-UP ROOT CAUSE: THE BLOWER MODULE HAS BEEN IDENTIFIED TO BE THE FAULTY COMPONENT. CORRECTION: BLOWER REPLACEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: ORIGINAL COMPLAINT: OUR SERVICE TECHNICIAN TURNED ON THE DEVICE IN ORDER TO CHECK IT. THEN, TECHNICAL EVENT 232006 OCCRRED. ANOTHER SERVICE TECHNICIAN REPLACED THE BLOWER MODULE, THEN TECHNICAL EVENT 232006 DISAPPEARED. HE INSTALLED THE ORIGINAL BLOWER MODULE AGAIN, THEN TECHNICAL EVENT 232006 OCCURRED AGAIN. COMPLAINT SUMMARY: TF 232006 (BLOWERTEMPERATURESENSORDEFECT) DURING START-UP.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO THE HAMILTON MEDICAL AG: ORIGINAL COMPLAINT: OUR SERVICE TECHNICIAN TURNED ON THE DEVICE IN ORDER TO CHECK IT. THEN, TECHNICAL EVENT (B)(4) OCCURRED. ANOTHER SERVICE TECHNICIAN REPLACED THE BLOWER MODULE, THEN TECHNICAL EVENT (B)(4)DISAPPEARED. HE INSTALLED THE ORIGINAL BLOWER MODULE AGAIN, THEN TECHNICAL EVENT (B)(4) OCCURRED AGAIN. COMPLAINT SUMMARY: (B)(4). (BLOWERTEMPERATURESENSORDEFECT) DURING START-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166 HAMILTON MEDICAL AG HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG HAMILTON-C6 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown