BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1982103 · Received February 8, 2011

    Report

    Report Number
    2031642-2011-00034
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS ALARMING AND SHUTTING DOWN INTERMITTENTLY WHILE IN USE. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE CUSTOMER REPORTED THEY WERE MOVING SOMETHING IN THE PATIENT'S ROOM AND BUMPED THE VENTILATOR AND IT WENT VENT INOP. THE CUSTOMER REPORTED THEY TOOK THE VENTILATOR OFF THE PATIENT TO CHECK IT OUT, AND AFTER EVALUATION THEY PUT IT BACK ON THE PATIENT AND IT SHUT DOWN AGAIN. THE MANUFACTURER'S SERVICE TECHNICIAN SPOKE WITH THE RESPIRATORY THERAPY SUPERVISOR WHO REPORTED THAT A PB 7200 VENTILATOR HAD PREVIOUSLY BEEN IN USE ON THE PATIENT AND HAD POWER ISSUES. THIS VENTILATOR WAS BROUGHT IN TO REPLACE IT AND HAD POWER ISSUES. AT THE SAME TIME THEY HAD A PROBLEM WITH 4 PULSE OXIMETERS IN THE SAME ROOM AT THE SAME TIME. THEY WERE ALL REPORTED TO BE USING ORANGE OUTLETS. THIS VENTILATOR WAS TAKEN INTO ANOTHER ROOM AND IT POWERED UP NORMALLY USING A WHITE OUTLET. THE CUSTOMER DECLINED SERVICE AT THE TIME THE EVENT WAS REPORTED. ON (B)(6) 2011 THE CUSTOMER REQUESTED ANNUAL PREVENTIVE MAINTENANCE ON THE DEVICE. DURING SERVICE OF THE DEVICE, THE MANUFACTURER'S SERVICE TECHNICIAN NOTED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A 24/12 VOLT POWER FAIL OCCURRENCE ON THE DATE THAT THE INITIAL PROBLEM WAS REPORTED WITH THE VENTILATOR INTERMITTENTLY SHUTTING DOWN AND FACILITY AC OUTLET PROBLEMS IN THE PATIENT'S ROOM. THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE FINDING. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS 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