BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO I

    MDR report key: 900449 · Received October 23, 2004

    Report

    Report Number
    8010042-2004-00106
    Event Type
    Malfunction
    Date Received
    October 23, 2004
    Date of Event
    September 22, 2004
    Report Date
    October 22, 2004
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CASE 1: VENT SETTINGS: PRVC, 21%, PEEP 6, RATE 30, VT 8ML, COMP ON, IT 0.3, RISE 0.15, NORMAL LUNGS, POST OP VENTILATION. THERAPIST NOTICED PAP 32 CMH2O W/EXAGGERATED CHEST EXCURSIONS, CASSETTE CLICKING SOUND, AND PRIOR PAP READINGS WERE 16 TO 19. PATIENT SUCTIONED, PAP> 30 POST. TUBING COMP TURNED OFF, VT SET TO 14ML, PAP NOW ~18. VT SET TO 8ML WITH COMP ON, PAP READINGS 18 TO 20. 2 HOURS LATER CUSTOMER NOTICED PAP WAS AGAIN> 30 WITH CASSETTE CLICKING. PATIENT WAS JUST RECONNECTED TO VENT AFTER BEING REPOSITIONED BY NURSE. COMP WAS MOMENTARILY TURNED OFF AND THEN ON AND PAP LOWERED TO ~18. PATIENT WAS DISCONNECTED FOR APPROX 5 SEC, RECONNECTED, AND PAP>30 AGAIN. CUSTOMER STATES THAT MOMENTARILY DISCONNECTING THE PATIENT CAUSES THE PROBLEM, AND TURNING COMP OFF AND THEN ON CORRECTS THE PROBLEM. CASE 2: VENT SETTINGS: PRVC, 100%, PEEP 6, VT 16ML, COMP ON, IT 0.3, RISE 0.15, PPHN 3.1KG, TERM INFANT, LARGE CUFF LEAK, PAP VERY HIGH AT 45 TO 50CMH2O. COMP TURNED OFF, VT 30ML, PAP DROPPED TO 30. CUSTOMER USED COSMO DURING CASE TO VERIFY DELIVERED PARAMETERS: AT VT 16, COMP ON, THE DELIVERED VOLUME WAS 28ML AT THE AIRWAY AND THE PAP WAS 45CMH2O. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    SUMMARY: CUSTOMER HAS REPEATEDLY NOTICED HIGH PEAK AIRWAY PRESSURE (PAP) WITH COMPLIANCE COMPENSATION (COMP) ON AND LOW SET TIDAL VOLUME (VT). CUSTOMER IS USING A COSMO TO MAKE THE CORRECT VT ADJUSTMENT WHEN COMP IS OFF AND VERIFYING VT WHEN COMP IS ON. IN CASE 1, CUSTOMER NOTICED PROBLEM OCCURS AFTER MOMENTARY PATIENT DISCONNECT AND THAT NORMAL PAP RESUMES AFTER COMP IS CYCLED OFF AND THEN ON. CASSETTE MAKES A CLICKING SOUND SIMILAR TO EXPIRATORY DIAPHRAGM BOTTOMING OUT WHEN PROBLEM OCCURS. REFERENCE LOGS 2004 16:04 HOURS. IN CASE 2, THE PATIENT HAD A LARGE CUFF LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO I RESPIRATORY VENTILATOR CBK MAQUET CRITICAL CARE AB 6487800 01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA