BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, CONTINUOUS, FACILITY USE

    MDR report key: 1022758 · Received March 28, 2008

    Report

    Report Number
    2518422-2008-00013
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K842876
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PLV-102 POSITIVE PRESSURE, PORTABLE VOLUME VENTILATOR SHUT DOWN WHILE IN PATIENT USE. THE SHUT DOWN OCCURRED WHEN THE VENTILATOR'S 5 AMP CIRCUIT BREAKER TRIPPED. THE VENTILATOR WAS REPORTED TO HAVE ACTIVATED A REMOTE ALARM THAT ALERTED THE CAREGIVER WHEN THE VENTILATOR SHUT DOWN. THE CUSTOMER WAS NOT AWARE IF THE VENTILATOR PRIMARY ALARM ACTIVATED CONCURRENTLY WITH THE REMOTE ALARM. WHEN THE CAREGIVER ARRIVED AT THE PT'S ROOM, THE PT WAS REPORTEDLY FOUND TO BE APNEIC AND HYPOXIC. THE PT WAS MANUALLY RESUSCITATED AND PLACED ON ANOTHER VENTILATOR. THE CUSTOMER STATES THE PT WAS RESTORED TO THEIR BASELINE CONDITION WITH NO ADVERSE EFFECTS FROM THE EVENT. A REVIEW OF THE MFR'S COMPLAINT DATABASE REVEALED NO INCREASING TRENDS IN CIRCUIT BREAKER FAILURES. A REVIEW OF THE MFR'S MDR DATABASE FOUND NO ADVERSE EVENTS RESULTING FROM AN UNPLANNED VENTILATOR SHUT DOWN WITH PRIMARY AND OR SECONDARY VENTILATOR ALARM ACTIVATION. THE MFR HAS REQUESTED ADDITIONAL INFO FROM THE CUSTOMER AND THE RETURN OF THE VENTILATOR FOR THEIR INVESTIGATION. AN MDR FOLLOW-UP WILL BE FILED WHEN THEIR INVESTIGATION IS COMPLETE.

    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 Life Threatening| R