BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4171079 · Received July 15, 2014

    Report

    Report Number
    8010042-2014-00315
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS EXAMINED BY THE DISTRIBUTOR AND WATER SPILLAGE WAS FOUND ON ALL PRINTED CIRCUIT (PC) BOARDS AND WATER AND COLLECTED IN THE DRAWERS AND EMPTY BATTERY SLOTS. THE VENTILATOR WAS DISMANTLED AND DRIED UP. THE PC BOARDS WERE CLEANED UP AND SW WAS REINSTALLED. HOWEVER ON STARTING UP OF THE VENTILATOR IT GENERATED A TECHNICAL ERROR CODE INDICATING A COMMUNICATION FAILURE. THE VENTILATOR HAS BEEN RETURNED FOR REPAIR. THE ROOT CAUSE WAS THE WATER SPILL THAT LED TO INGRESS INTO THE VENTILATOR. REF EXEMPTION #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE WAS PREPARING THE VENTILATOR FOR USE. THE NURSE WAS INSTALLING A DISTILLED WATER BAG THAT IS USED FOR ACTIVE HUMIDIFICATION WHEN SHE WAS CALLED FOR AN EMERGENCY SITUATION AND SHE LEFT THE ROOM. WHILE THE NURSE WAS AWAY, THE WATER BAG FILLED THE PT CIRCUITRY. THERE WAS NO PT INVOLVEMENT. MFR REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413667 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1