BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 819466 · Received February 15, 2007

    Report

    Report Number
    8010042-2007-00028
    Event Type
    Death
    Date Received
    February 15, 2007
    Date of Event
    January 19, 2007
    Report Date
    January 19, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K041223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVALUATION INDICATES NO VENTILATOR FAILURE. INVESTIGATION IS ONGOING. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTS THAT AT APPROXIMATELY 4 PM IN 2007, AN ACUTELY ILL, INTUBATED PATIENT HAD BEEN TRANSPORTED FROM THE BURN ICU TANK ROOM BACK TO THEIR ROOM, ASSISTED VENTILATION VIA AMBU BAG-WITH RESPIRATORY THERAPIST AND NURSE. UPON RETURNING TO THE ROOM, THE PATIENT WAS TRANSFERRED INTO BED AND PLACED BACK ON THE SERVO-I, WHICH HAD BEEN MAINTAINED IN STANBY WHILE PATIENT WAS IN THE TANK ROOM. THE RESPIRATORY THERAPIST CONNECTED THE PATIENT AND STARTED VENTILATION WHILE POSITIONED BEHIND THE VENTILATOR BY REACHING AROUND TO THE FRONT OF THE SCREEN. IN A BRIEF WINDOW OF TIME, ABOUT 4 MINUTES, THE VENTILATOR WAS ALARMING REPEATEDLY AND THE ALARMS WERE SILENCED. WHEN THE THERAPIST WAS ABLE TO VISUALIZE THE SCREEN AND ALARMS, THE TIDAL VOLUME WAS LOW AND THE VENTILATOR DETERMINED TO BE SET TO INFANT CONFIGURATION, NOT ADULT (WHICH WAS THE SELECTION PRIOR TO STANDBY). THE PATIENT REQUIRED RESUSCITATION WHICH WAS SUCCESSFUL. FOUR HOURS LATER, THE PATIENT HAD A MEDICAL EVENT REQUIRING RESUSCITATION. THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death