BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 19199364 · Received April 29, 2024

    Report

    Report Number
    3001421318-2024-01035
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 19, 2024
    Report Date
    November 5, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED/CORRECTED: SECTION H6 IMDRF CODE WAS WRONG. CORRECTE IMDRF: A1603. HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: DEFECTIVE MAINBOARD CORRECTION: REPLACED DEFECTIVE COMPONENT.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: DEFECTIVE MAINBOARD CORRECTION: REPLACED DEFECTIVE COMPONENT.

    Additional Manufacturer Narrative · 0

    ADDED/CORRECTED: SECTION H6 IMDRF CODE WAS WRONG. CORRECT IMDRF: A1603. HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOTCAUSE: DEFECTIVE MAINBOARD. CORRECTION: REPLACED DEFECTIVE COMPONENT. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (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, D2A, D4, D8, G1, G2, G6, H2, H4, H5.

    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
    887337 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown