BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 3221083 · Received July 8, 2013

    Report

    Report Number
    3008355164-2013-00162
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PT INVOLVEMENT. (B)(4). REF MFR REPORT 8010042-2013-001040.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309069 SERVO-S CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA