BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3915321 · Received May 27, 2014

    Report

    Report Number
    8010042-2014-00231
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER HAS BEEN ONSITE 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 THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED INTERNAL LEAKAGE TEST, PRESSURE TRANSDUCER TEST AND FLOW TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311520 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1