BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPAP S/T C SERIES

    MDR report key: 3192117 · Received June 20, 2013

    Report

    Report Number
    2518422-2013-01265
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K092818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP S/T C SERIES WAS NOT WORKING PROPERLY. THE PATIENT REPORTEDLY HAD A SEIZURE. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. 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
    280602 BIPAP S/T C SERIES VENTILATOR, CONTINUOUS, NON-LIFESUPPORTING MNS RESPIRONICS, INC. 1061401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other