BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 18003346 · Received October 25, 2023

    Report

    Report Number
    3001421318-2023-03648
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 9, 2023
    Report Date
    August 7, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: CER (B)(4). HAMILTON MEDICAL AG`S CONCLUSION IS THE FOLLOWING: ROOT CAUSE: DEFECTIVE PRESSURE SENSOR ASSEMBLY. LEAK IN PRESSSURE SENSOR ASSEMBLY. CORRECTION: REPLACEMENT OF THE PRESSURE SENSOR ASSEMBLY. HAMILTON MEDICAL AG COMPLAINT NUMBER: CER 143165 FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION AS REQUESTED. UPDATED FIELDS: B4, D1, D3, D4, G1, G3, G6, H2, H4.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4). HAMILTON MEDICAL AG`S CONCLUSION IS THE FOLLOWING: ROOT CAUSE: DEFECTIVE PRESSURE SENSOR ASSEMBLY. LEAK IN "PRESSURE" SENSOR ASSEMBLY. CORRECTION: REPLACEMENT OF THE PRESSURE SENSOR ASSEMBLY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING SERVICE SOFTWARE: PRESSURE SENSOR ASSEMBLY TEST FAILS. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DURING SERVICE SOFTWARE: PRESSURE SENSOR ASSEMBLY TEST FAILS. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432929 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown