BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 18202817 · Received November 23, 2023

    Report

    Report Number
    3001421318-2023-10500
    Event Type
    Malfunction
    Date Received
    November 23, 2023
    Date of Event
    September 26, 2022
    Report Date
    August 31, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN ONE YEAR 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 IN USE. THE ROOT CAUSE WAS DETERMINED TO BE A CLOGGED/OBSTRUCTED FILTER DUE TO THE THERAPY SETTINGS. THERE WAS NO PATIENT OR USER HARM REPORTED. FOR ANNEX C THE INVESTIGATOR CHOSE 4253 - BLOCKAGE IDENTIFIED. THIS CODE IS NOT YET AVAILABLE IN THE ESUBMITTER. THEREFORE THE ANNEX C FIELD REMAINS EMPTY BUT THE CODE WILL BE MARKED HERE IN THE CONCLUSION. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4).

    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: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN ONE YEAR 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 IN USE. THE ROOT CAUSE WAS DETERMINED TO BE A CLOGGED/OBSTRUCTED FILTER DUE TO THE THERAPY SETTINGS. THERE WAS NO PATIENT OR USER HARM REPORTED. FOR ANNEX C THE INVESTIGATOR CHOSE 4253 - BLOCKAGE IDENTIFIED. THIS CODE IS NOT YET AVAILABLE IN THE ESUBMITTER. THEREFORE THE ANNEX C FIELD REMAINS EMPTY BUT THE CODE WILL BE MARKED HERE IN THE CONCLUSION.

    Description of Event or Problem · 0

    CUSTOMER EMAILED REGARDING A EXHALATION OBSTRUCTION ALARM DURING VENTILATION.

    Description of Event or Problem · 0

    CUSTOMER EMAILED REGARDING A EXHALATION OBSTRUCTION ALARM DURING VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188149 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown