BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 19678077 · Received July 5, 2024

    Report

    Report Number
    3001421318-2024-01603
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 28, 2024
    Report Date
    November 18, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: 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 BROKEN SEAL RING IN THE INSPIRATORY VALVE. IN CONSEQUENCE THE VALVE WAS REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Additional Manufacturer Narrative · 0

    A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: 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 BROKEN SEAL RING IN THE INSPIRATORY VALVE. IN CONSEQUENCE THE VALVE WAS REPLACED. THERE WAS NO PATIENT OR USER HARM REPORTED. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 2 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D3, D4, G1, G6, H2, H4, H5, H11.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TECHNICAL EVENT 231005 (INSPIRATION VALVE LEAK) APPEARED VARIOUS TIMES DURING VENTILATION. DEVICE REMOVED FROM USE, ALTERNATIVE VENTILATION USED. NO PATIENT HARM.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TECHNICAL EVENT 231005 (INSPIRATION VALVE LEAK) APPEARED VARIOUS TIMES DURING VENTILATION. DEVICE REMOVED FROM USE, ALTERNATIVE VENTILATION USED. NO PATIENT HARM.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: TECHNICAL EVENT 231005 (INSPIRATION VALVE LEAK) APPEARED VARIOUS TIMES DURING VENTILATION. DEVICE REMOVED FROM USE, ALTERNATIVE VENTILATION USED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477587 HAMILTON-C6 HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown