BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3874572 · Received April 22, 2014

    Report

    Report Number
    8010042-2014-00173
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAKING AIR GAS MODULE WAS REPLACED AND THE REPORTED VENTILATOR WAS PUT BACK IN SERVICE. REPLACED PART HAS BEEN REQUESTED FOR INVESTIGATION BUT NOT YET RECEIVED. A SUPPLEMENTAL MDR REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERFORMANCE OF PREVENTIVE MAINTENANCE ON THE VENTILATOR LEAKAGE WAS OBSERVED FROM THE AIR GAS MODULE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242895 SERVO-I CBK CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1