BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C6

    MDR report key: 18009220 · Received October 26, 2023

    Report

    Report Number
    3001421318-2023-03660
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 4, 2023
    Report Date
    August 9, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER: (B)(4). HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: LEAK IN "PRESSURE" SENSOR ASSEMBLY. CORRECTION: REPLACE THE PRESSURE SENSOR ASSEMBLY.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER: (B)(4). HAMILTON MEDICAL AG COMES TO THE CONCLUSION: ROOT CAUSE: LEAK IN PRESSSURE SENSOR ASSEMBLY. CORRECTION: REPLACE THE PRESSURE SENSOR ASSEMBLY. HAMILTON MEDICAL AG COMPLAINT NUMBER: (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: SUMMARY: DURING SERVICE SOFTWARE : PRESSURE SENSOR ASSEMBLY TEST FAILS. NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567603 HAMILTON-C6 HAMILTON-C6 CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown