BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16766506 · Received April 19, 2023

    Report

    Report Number
    3001421318-2023-01487
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    April 10, 2023
    Report Date
    April 19, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMES TO THE FOLLOWING CONCLUSION: FAILURE MODE DESCRIPTION: STATE OF FAILURE: VENTILATION AFFECTED COMPONENT: BLOWER MODULE FAILURE EFFECT: DEVICE ALARMS WITH HIGH PRIORITY TECHNICAL EVENT: 231009 (ALARM BLOWER SPEED LOW). => VENTILATION CONTINUES. ROOT CAUSE: DEFECTIVE BLOWER THE BLOWER SPEED IS LOWER THAN THE TARGET SPEED-5% FOR MORE THAN 5S. CORRECTION: -REPLACEMENT OF THE BLOWER MODULE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: TF 231009 - BLOWER FAILURE ERROR TF 431002 - MAIN BOARD/ BLOWER FAILURE ERROR BLOWER TIMER REACHED 100% AND BLOWER SERVICE REQUIRED INDICATION OCCURRED TF 231001 - TIGHTNESS TEST FAILS. SUMMARY: TECHNICAL EVENT:231009 DUE TO DEFECTIVE BLOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686233 HAMILTON MEDICAL AG HAMILTON-C3 VENTILATOR CBK HAMILTON MEDICAL AG 160021 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown