BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPIRIT VENTILATOR

    MDR report key: 1083578 · Received July 24, 2008

    Report

    Report Number
    2031642-2008-00168
    Event Type
    Other
    Date Received
    July 24, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 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
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT VENTILATOR ALARMED AND SHUT DOWN WHILE OPERATING ON BACKUP BATTERY POWER WHEN MOVING A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MFR'S SERVICE TECHNICIAN REPORTED THE UNIT WAS EQUIPPED WITH AN EXTERNAL BATTERY AND BACK UP BATTERY. THE SERVICE TECHNICIAN REPORTED FINDING THE EXTERNAL BATTERY SWITCH SET TO THE OFF POSITION. THE CUSTOMER WAS RUNNING THE VENTILATOR OFF OF AC POWER, SO THE BACKUP BATTERY WAS IN USE WHICH HAD BECOME DEPLETED DURING USE, RESULTING IN THE VENTILATOR ALARMING AND SHUTTING DOWN. THE BACKUP BATTERY WAS REPLACED AS A PREVENTIVE MEASURE, EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED TO SPECIFICATIONS. WHEN THE VENTILATOR IS EQUIPPED WITH A BACK UP BATTERY AND IT IS IN USE, THE VENTILATOR ALARM INDICATING THE BACKUP BATTERY IS THE POWER SOURCE FOR VENTILATOR OPERATION. THE USER ALLOW THE BACKUP BATTERY TO DEPLETE UPON USE, CONTRIBUTING TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK