BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1213403 · Received October 29, 2008

    Report

    Report Number
    2031642-2008-00222
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Removal / Correction Number
    Z-2002-04-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE BACKUP BATTERY IN USE WITH THE VENTILATOR WOULD NOT CHARGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AND THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE DISTRIBUTOR REPORTED UPON INSPECTION OF THE VENTILATOR FOR THE REPORTED PROBLEM, THERE WAS HEAT RELATED DAMAGE NOTED TO THE POWER SUPPLY SNUBBER BOARD. THE DISTRIBUTOR REPLACED THE SNUBBER BOARD AS DIRECTED PER FIELD ACTION, AND THE POWER SUPPLY TO CORRECT THE REPORTED PROBLEM OF THE BACKUP BATTERY NOT CHARGING. DAMAGE TO THE POWER SUPPLY SNUBBER PCB MAY RESULT IN A MALFUNCTION OF THE POWER SUPPLY WHICH COULD CAUSE THE VENTILATOR TO SHUT DOWN.

    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