BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO I

    MDR report key: 617600 · Received August 7, 2004

    Report

    Report Number
    8010042-2004-00074
    Event Type
    Malfunction
    Date Received
    August 7, 2004
    Date of Event
    July 10, 2004
    Report Date
    August 2, 2004
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S ACCOUNT OF EVENT AS PER NOTE LEFT ON UNIT: "PT INSTALLED ON VENTILATOR, INITIALLY FUNCTIONING, 5 MINUTES LATER VENTILATOR RINGING APNEA OCCURRED, 0 WAVE FORMS, 0 BREATHS. TRIED TO GIVE MANUAL BREATHS, 0 BREATHS DELIVERED. TECHNICAL ERROR 11 DISPLAYED. IN THE LOGS THE UNIT GAVE TWO ERRORS SHORTLY AFTER ITS POWER WENT ON, 10/2004, 17:43:15, TECH ALARM MONITORING PANEL DISCONNECTED AND 10/2004, 17:45:22, TECH ALARM MONITORING TECHNICAL ERROR: 11."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO I RESPIRATORY VENTILATOR CBK MAQUET CRITICAL CARE AB 6487800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA