BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I

    MDR report key: 3030238 · Received March 28, 2013

    Report

    Report Number
    8010042-2013-00044
    Event Type
    Injury
    Date Received
    March 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR¿S ALARM SOUND LEVEL HAS A SETTING OF 10-100%. AT 100% THE SOUND LEVEL IS APPROX 70 DB AND AT 10% THE LEVEL IS 60 DB WHICH IS ABOVE THE MINIMUM LEVEL 45 DB ACCORDING TO THE STANDARD ISO 9703-2 THAT WAS APPLICABLE AT THE TIME OF THE VENTILATOR DESIGN. THE VENTILATOR SYSTEM OFFERS AN ALARM BOOSTER KIT WHICH ENABLES THE SOUND LEVEL AT 100% TO BE APPROXIMATELY 77 DB AND AT 10% TO BE APPROXIMATELY 66DB. IN ADDITION, AN EXTERNAL ALARM OUTPUT CONNECTOR WHICH IS A NON-GUARANTEED ALARM IN ACCORDANCE WITH IEC60601-1-8 AND CAN BE INSTALLED, WILL ENABLE COMMUNICATION OF HIGH AND MEDIUM PRIORITY ALARMS. THERE IS NO REPORTED VENTILATOR MALFUNCTION AT THE TIME. THE VENTILATOR ALARMED AS IT SHOULD WITH THE SOUND LEVEL THAT WAS SET AT THE TIME. THE REPORTED LOWERING OF THE ALARM SOUND LEVEL IS AN ACTIVE PERFORMED TO SUIT THE SURROUNDING ENVIRONMENT. THE CAUSE OF THE EVENT WAS A COMBINATION OF THREE FACTORS NAMELY: LOWERING THE ALARM SOUND LEVEL, CLOSING THE DOOR AND LEAVING THE PATIENT UNATTENDED AND NONE OF THESE CAN BE ATTRIBUTED TO THE FUNCTIONING OF THE VENTILATOR. THE USER CAN ADJUST THE SOUND LEVEL AT ANY TIME TO SUIT THE ENVIRONMENT, AS DETERMINED BY THE USER. THE SAME APPLIES TO THE CHANGING OF THE ALARM SOUND DEFAULT VALVE TO START-UP. THE USER IS CAUTIONED NOT TO LEAVE THE PATIENT UNATTENDED. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING THAT: "(B)(6) MEMBER FACILITY REPORTED THAT A PT WAS INJURED WHEN CLINICIANS, OUTSIDE OF THE PATIENT'S ROOM, DID NOT HEAR A BREATHING CIRCUIT DISCONNECTION ALARM ON A VENTILATOR. ALTHOUGH THE ALARM VOLUME WAS SET AT 60%, HOSPITAL STAFF REPORTED THAT AT 100%, THE ALARM COULD NOT BE HEARD WITH THE PATIENT'S ("DOOR CLOSED.")" (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127472 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Life Threatening