BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1011325 · Received March 11, 2008

    Report

    Report Number
    2031642-2008-00069
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOOSE POWER CORD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR LOST AC POWER WHILE IN USE ON A PT. THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING, AND THERE WAS NO PT HARM. THE MFR'S SVC TECH REPORTED THE VENTILATOR WOULD NOT POWER ON EITHER WITH AC OR BACKUP BATTERY POWER. UPON EVAL, THE SVC TECH REPORTED FINDING THE AC POWER CORD WAS NOT FULLY SEATED INTO THE BACK OF THE VENTILATOR. THE SVC TECH RESEATED THE POWER CORD AND SECURED THE POWER CORD CLAMP TO CORRECT THE PROBLEM. THE SVC TECH REPORTED THE BACKUP BATTERY WAS FULLY DEPLETED FROM USE UPON LOSS OF AC POWER, SO THE BACKUP BATTERY WAS REPLACED. EXTENDED SELF TESTING (EST) WAS PERFORMED AND PASSED PER OPERATING SPECIFICATIONS.

    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 UNK