BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1891903 · Received November 5, 2010

    Report

    Report Number
    2031642-2010-00306
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE REMOTE ALARM CABLE WAS DAMAGED AND THE WIRING WAS DISCONNECTED FROM THE MOLDED CONNECTOR ONE END OF THE CABLE. FACTORY ANALYSIS CONFIRMED THE REPORTED PROBLEM, AND VISUAL INSPECTION OF THE INTERIOR OF THE MOLDED CONNECTOR REVEALED THAT PART OF THE WIRING IS STILL ATTACHED TO THE CONNECTOR WHICH INDICATES THAT ENOUGH FORCE WAS APPLIED TO THIS CABLE TO SNAP THE WIRES AND DISLODGE THE CABLE FROM THE MOLDED CONNECTOR. THE VENTILATOR IS EQUIPPED WITH A REMOTE ALARM PORT ALLOWING VENTILATOR ALARM CONDITIONS TO BE SOUNDED AT REMOTE LOCATIONS AWAY FROM THE VENTILATOR. THE CABLE DAMAGE FOUND DURING ANALYSIS MAY CAUSE THE REMOTE ALARM TO FAIL TO ALERT THE USER UPON VENTILATOR ALARM ACTIVATION. THE VENTILATOR OPERATORS MANUAL INDICATES THE USER SHOULD FULLY TEST THE REMOTE ALARM AND CABLE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 REMOTE ALARM CABLE