BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3121748 · Received May 8, 2013

    Report

    Report Number
    3008355164-2013-00114
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT, IT GENERATED TECHNICAL ERROR CODES INDICATING DISABLED VALVES AND COMMUNICATION FAILURE BETWEEN THE CONTROL AND MONITORING PRINTED CIRCUIT BOARDS. THE FAILURE PERSISTED EVEN AFTER THE VENTILATOR WAS RESTARTED. THERE WAS NO PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201607 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI