BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 19738577 · Received July 15, 2024

    Report

    Report Number
    3001421318-2024-01695
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    July 10, 2024
    Report Date
    October 25, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: CHECKED THE SYSTEM AND FOUND, SYSTEM IS NOT FUNCTIONING BECAUSE OF SYSTEM IS SHOWING TECHNICAL EVENT 232035 (PFILTER SELFTEST FAILED). NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: CHECKED THE SYSTEM AND FOUND, SYSTEM IS NOT FUNCTIONING BECAUSE OF SYSTEM IS SHOWING TECHNICAL EVENT 232035 (PFILTER SELFTEST FAILED). NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258542 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown