BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE ALARM

    MDR report key: 3190447 · Received June 19, 2013

    Report

    Report Number
    2518422-2013-01266
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K862212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER CONFIRMED THE CUSTOMER'S COMPLAINT. THE LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PRESSURE ALARM'S SCREEN WAS BLANK. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279422 PRESSURE ALARM VENTILATOR CBK RESPIRONICS, INC. 23001

    Patients

    Seq Age Sex Outcome Treatment
    1