BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 3221107 · Received July 8, 2013

    Report

    Report Number
    3008355164-2013-00164
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    January 5, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. THERE WAS NO PT INVOLVEMENT. (B)(4). REF MFR REPORT 8010042-2013-00105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308880 SERVO-S CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA