BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2941603 · Received January 31, 2013

    Report

    Report Number
    8010042-2013-00013
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 3, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR FIELD SERVICE ENGINEER HAS BEEN ON SITE AND HAS STARTED THE INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION IS FINISHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR SHUTDOWN WHILE IT WAS CONNECTED TO A PATIENT. THERE WAS NO PATIENT INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42521 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI