BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C3

    MDR report key: 19266253 · Received May 8, 2024

    Report

    Report Number
    3001421318-2024-01117
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    April 25, 2023
    Report Date
    November 12, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801881
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    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

    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, D2A, D4, D8, G1, G2, G6, H2, H4, H5.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: A SELF-TEST ERROR OCCURRED WHEN THE DEVICE WAS TURNED ON WITH TECHNICAL FAULTS 444004, 431001, 431006, 231032 UNIT DOESN'T START UP (BLUE BOOT SCREEN).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: A SELF-TEST ERROR OCCURRED WHEN THE DEVICE WAS TURNED ON WITH TECHNICAL FAULTS 444004, 431001, 431006, 231032 UNIT DOESN'T START UP (BLUE BOOT SCREEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782733 HAMILTON-C3 HAMILTON-C3 CBK HAMILTON MEDICAL AG 160005 07630002801881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown