BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V200 VENTILATOR

    MDR report key: 1792263 · Received August 10, 2010

    Report

    Report Number
    2031642-2010-00217
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PARTS NOT RETURNED FROM (B)(4) DUE TO CUSTOMS COSTS. POWER SUPPLY. PARTS NOT RETURNED DUE TO CUSTOMS COSTS.

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR REPORTED THE VENTILATOR WOULD NOT OPERATE ON AC POWER. THE CUSTOMER REPORTED THE UNIT WAS IN USE ON A PATIENT, AND THERE WAS NO PATIENT HARM. THE DISTRIBUTOR REPLACED THE POWER SUPPLY TO CORRECT THE REPORTED PROBLEM. IF A FAILURE OF THE POWER SUPPLY OCCURS DURING USE AND THE VENTILATOR SHUTS DOWN, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V200 VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1