BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE.

    MDR report key: 2464115 · Received February 14, 2012

    Report

    Report Number
    2518422-2012-00096
    Event Type
    Other
    Date Received
    February 14, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K842876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL, AND THE CUSTOMER'S COMPLAINT COULD NOT BE DUPLICATED. THE DEVICE WAS FOUND TO AUDIBLY AND VISUALLY ALARM AS DESIGNED. FOR THE REPORTED EVENT, THE DEVICE IS DESIGNED WITH A 15 SECOND ALARM DELAY. THE MFR BELIEVES THAT THE REPORTER OF THE EVENT DID NOT GIVE THE MACHINE LONG ENOUGH TIME TO ALARM. THE DEVICE OPERATED TO SPECS.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR DID NOT ALARM WHEN THE PT BECAME DISCONNECTED. THERE WAS NO PT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, FACILITY USE. PLV 102B CBK RESPIRONICS INC 1003111

    Patients

    Seq Age Sex Outcome Treatment
    1