BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 8400746 · Received March 7, 2019

    Report

    Report Number
    2031642-2019-01344
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Report Date
    February 12, 2019
    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

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 07MARCH2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) PERFORMED REMOTE TROUBLESHOOTING WITH THE CUSTOMER. THE FSE SUSPECTED THAT THE UNIT WAS OPERATING ON BATTERY POWER WHEN THE ERROR OCCURRED AND THAT THE UNIT JUST NEEDED TO BE RESET. THE CUSTOMER REPORTED THAT THE UNIT THEN DECLARED AN ERROR 3131 (PATIENT WYE NOT BLOCKED) AND THAT THE INSPIRATORY TRANSDUCER WAS READING 9 CMH2O AND THE EXHALATION TRANSDUCER READ 13CMH2O. THE FSE ADVISED THE CUSTOMER TO CHECK TO SEE IF THE INSPIRATORY AND EXPIRATORY TRANSDUCERS WERE KINKED. THE CUSTOMER REPORTED THAT ONE OF THE PRESSURE TRANSDUCER LINES WERE PINCHED. THE CUSTOMER RE-ROUTED THE LINES AND THE ISSUE WAS RESOLVED. THE DEVICE PASSED EXTENDED SELF TESTING (EST).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DECLARED AN ERROR 1014 (24 VOLT FAILURE) AFTER THE POWER SUPPLY AND BATTERY WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. EVENT DATE NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195053 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1