BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2526116 · Received April 10, 2012

    Report

    Report Number
    2031642-2012-00159
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 23, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RESPIRATORY CARE MANAGER REPORTED THE FOLLOWING: ON (B)(6) 2012, THE NURSING ASSISTANT NOTICED THAT THE FEMALE PATIENT'S VISUAL CALL LIGHT WAS ON AND WENT INTO THE ROOM. THE NURSING ASSISTANT REPORTED THE PATIENT DIDN'T LOOK GOOD AND WAS TRYING TO GET HER ATTENTION. THE NURSING ASSISTANT REPORTED THE VENTILATOR MONITOR WAS BLACK AND THE VENTILATOR WAS OFF. THE PATIENT'S OXYGEN SATURATION WAS DECREASING INTO THE 60'S AND SHE WAS BECOMING DUSKY / BLUE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND VENTILATED MANUALLY WITH O2 SATURATION INCREASING BACK TO 90'S. THE VENTILATOR WAS POWERED BACK ON AND DISPLAYED A COUNTDOWN AND WOULD NOT START BACK INTO NORMAL VENTILATION MODE. THE VENTILATOR WAS REMOVED FROM USE AND SET ASIDE WITH CIRCUIT INTACT. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR WITHOUT PERMANENT HARM. THE VENTILATOR HAD BEEN CONNECTED TO THE FACILITY REMOTE ALARM SYSTEM AND IT WAS REPORTED THAT WHEN THE VENTILATOR SHUT DOWN DURING THE EVENT IT DID NOT ALARM AND DID NOT ACTIVATE AN AUDIBLE ALARM REMOTELY. UPON EVALUATION OF THE DEVICE, THE MANUFACTURERS SERVICE TECHNICIAN REPORTED THE VENTILATOR WOULD NOT POWER ON WITH EITHER AC OR BATTERY POWER. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING, INCLUDING THE POWER FAIL ALARM, WAS PERFORMED AND TESTS PASSED TO OPERATING SPECIFICATIONS. THE SERVICE TECHNICIAN REPORTED THE BATTERIES WERE FULLY DEPLETED, WERE CHARGED FOR 24 HOURS AND WERE RECHARGED AND OPERATIONAL.

    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 Required Intervention