BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILTIY USE

    MDR report key: 2241156 · Received August 17, 2011

    Report

    Report Number
    2518422-2011-00091
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K832467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER WITH AN ALLEGATION THE DEVICE WAS ALARMING FOR LOW PRESSURE AND HAD NO FLOW. THERE WAS NO PATIENT HARM OR INJURY. THE REPAIR TECHNICIAN CONFIRMED THE CUSTOMER'S COMPLAINT. THE DEVICE WAS FOUND TO HAVE A CORRODED BALL SCREW ASSEMBLY WHICH CAUSED THE VENTILATOR TO STALL. THE BALL SCREW ASSEMBLY WAS REPLACED TO CORRECT THE PROBLEM. THERE WAS NO PATIENT HARM OR INJURY. THE VENTILATOR WAS FOUND TO AUDIBLY AND VISUALLY ALARM APPROPRIATELY FOR A LOW PRESSURE CONDITION. THE MANUFACTURER WILL CONTINUE TO TREND LIFE SUPPORT VENTILATOR MALFUNCTIONS THAT COULD POTENTIALLY RESULT IN A LOSS OF THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, CONTINUOUS, FACILTIY USE PLV-100 CBK RESPIRONICS INC. 35006

    Patients

    Seq Age Sex Outcome Treatment
    1