BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3251900 · Received July 24, 2013

    Report

    Report Number
    8010042-2013-00113
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SVC ENGINEER HAS BEEN ON SITE AND TROUBLESHOOTED THE REPORTED VENTILATOR. THE REPORTED PROBLEM HAS BEEN REPRODUCED AND THE EXPIRATORY PRESSURE TRANSDUCER BOARD HAS BEEN REPLACED. REPLACED PART HAS BEEN REQUESTED FOR INVESTIGATION. A SUPPLEMENTAL MDR REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345016 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1