BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 18316465 · Received December 13, 2023

    Report

    Report Number
    3001421318-2023-04161
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 30, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: CER (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING THE DAILY INSPECTION OF DEPARTMENTAL EQUIPMENT, THERE IS AN ALARM FOR EQUIPMENT FLOW SENSOR FAILURE. REPORT FOR REPAIR IMMEDIATELY THE HOSPITAL ANALYSIS: FLOW SENSOR MALFUNCTION NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING THE DAILY INSPECTION OF DEPARTMENTAL EQUIPMENT, THERE IS AN ALARM FOR EQUIPMENT FLOW SENSOR FAILURE. REPORT FOR REPAIR IMMEDIATELY THE HOSPITAL ANALYSIS: FLOW SENSOR MALFUNCTION NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694045 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown