BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 19283760 · Received May 10, 2024

    Report

    Report Number
    3001421318-2024-01132
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    December 7, 2023
    Report Date
    October 23, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (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, H11.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE HOSPITAL STAFF TURNED ON THE C1 TO CHECK THIS C1. AT THAT TIME, TECHNICAL EVENT:232002 AND 233001 AND SELF TEST FAILED APPEARED ON THE SCREEN AND AN ALARM WENT OFF. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE HOSPITAL STAFF TURNED ON THE C1 TO CHECK THIS C1. AT THAT TIME, TECHNICAL EVENT:232002 AND 233001 AND SELF TEST FAILED APPEARED ON THE SCREEN AND AN ALARM WENT OFF. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122011 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown