BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 19496467 · Received June 10, 2024

    Report

    Report Number
    3001421318-2024-01385
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    June 4, 2024
    Report Date
    December 17, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H5, H11.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: THE INVESTIGATION CONFIRMED THAT DEVICE DID NOT WORK AS INTENDED AT THE TIME OF THE EVENT. THE INCIDENT REPORTED BY THE CUSTOMER OCCURRED DURING START-UP WITHOUT PATIENT INVOLVEMENT. THEREFORE, THERE WAS NO PATIENT OR USER HARM. THE ROOT CAUSE WAS A DEFECTIVE FFC-CABLE (PART N° 161554). THE DEFECTIVE CABLE WAS EXCHANGED, THE DEVICE WAS TESTED AND WORKED AS INTENDED AGAIN.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:TF 243004 (BUZZER DEFECT AT STARTUP) OR BUZZER DEFECTIVE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:TF 243004 (BUZZER DEFECT AT STARTUP) OR BUZZER DEFECTIVE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY:TF 243004 (BUZZER DEFECT AT STARTUP) OR BUZZER DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206207 HAMILTON-C6 HAMILTON-C6 VENTILATOR CBK HAMILTON MEDICAL AG 160021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown