BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3912107 · Received May 13, 2014

    Report

    Report Number
    8010042-2014-00196
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER HAS BEEN ON SITE AND STARTED THE INVESTIGATION. THE AIR GAS MODULE WAS FOUND DEFECTIVE AND HAS BEEN REPLACED. THE REPLACED PART HAS BEEN REQUESTED BUT NOT YET RECEIVED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARM INDICATING LOW EXPIRATORY MINUTE VOLUME WAS GENERATED DURING PATIENT TREATMENT. THE VENTILATOR WAS REPLACED. THERE WAS NO HARM TO PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285571 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1