BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 1581055 · Received January 15, 2010

    Report

    Report Number
    2518422-2010-00003
    Event Type
    Other
    Date Received
    January 15, 2010
    Date of Event
    December 15, 2009
    Report Date
    December 17, 2009
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K842876
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED ALLEGING A VENTILATOR FAILED TO DELIVER ADEQUATE THERAPY WHILE IN USE ON A PATIENT. THE PATIENT REPORTEDLY REQUIRED HOSPITALIZATION FOLLOWING THE EVENT. THE COMPLAINANT CONFIRMED THE VENTILATOR WAS SOUNDING AN AUDIBLE LOW-PRESSURE ALARM AT THE TIME OF THE EVENT. THE PATIENT HAS RECOVERED AND RETURNED HOME ACCORDING TO THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT WHEN THE INVESTIGATION FOR THE REPORTED EVENT IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, FACILITY USE PLV-102 CBK RESPIRONICS, INC. 37001

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R