BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUME VENTILATOR

    MDR report key: 1242870 · Received November 19, 2008

    Report

    Report Number
    2183157-2008-00012
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR FAILURE TO CYCLE WAS VERIFIED, HOWEVER, THE UNIT DID ALARM AS DESIGNED. THIS UNIT WAS EQUIPPED WITH THE ORIGINAL LOGIC BOARD WHICH IS OVER 10 YEARS OLD.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A REPORT THAT WHILE IN PATIENT USE THE UNIT STOPPED VENTILATING WITHOUT AN AUDIBLE ALARM. ALL VISUAL ALARMS WERE LIT. IT WAS REPORTED THAT A TRAINED CAREGIVER WAS IN THE ROOM BUT THE PATIENT EXPERIENCED A DROP IN THE PULSE OXIMETER READING TO 84% SP02. THE UNIT WAS REMOVED FROM PATIENT. THE PATIENT WAS AMBU BAG VENTILATED UNTIL THE SP02 RECOVERED TO 94-95%. THE PATIENT WAS PLACED ON A BACK UP LP VENTILATOR SOME TIME LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLUME VENTILATOR VENTILATOR CBK NELLCOR PURITAN BENNETT LP-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention