BEUDAMED
    FDA Adverse Event Summary report: N

    SERVO-I

    MDR report key: 3111100 · Received April 9, 2013

    Report

    Report Number
    3008355164-2013-00087
    Date Received
    April 9, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN INQUIRY AND A COPY OF A USER MEDWATCH REPORT #(B)(4) WAS RECEIVED FROM THE FDA STATING THAT: TECHNICAL ERROR-40001 OCCURRED WHILE PT WAS ON VENTILATOR. PT NOT IN DISTRESS AND WAS SWITCHED TO TX. VENTILATOR WAS PLACED ON STANDBY AND ASSESSED. VENTILATOR WAS TURNED OFF AND PRE-USE CHECK DONE 2 TIMES WITH THE WORD "FAILED" IMMEDIATELY APPEARING ON ALMOST ALL THE PRE-USE CHECK LISTS. VENTILATOR WAS REMOVED FROM SERVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147926 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI