BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPAP AVAPS C SERIES

    MDR report key: 2851026 · Received November 21, 2012

    Report

    Report Number
    2518422-2012-02329
    Event Type
    Other
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K092818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT ARRESTED AND REQUIRED CARDIOPULMONARY RESUSCITATION WHILE A BIPAP AVAPS C SERIES DEVICE WAS IN USE. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL BY AMBULANCE. THE PATIENT HAS SINCE BEEN DISCHARGED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP AVAPS C SERIES NONE CBK RESPIRONICS, INC. 1060657 1060657

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention