BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 6054552 · Received October 25, 2016

    Report

    Report Number
    2031642-2016-02862
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    September 30, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    FAILURE INVESTIGATION (FI) LAB RECEIVED THE POWER SUPPLY FOR EVALUATION. VISUAL INSPECTION OF THE POWER SUPPLY REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. FI TECHNICIAN TESTED THE POWER SUPPLY AND CONFIRMED THAT THE VENTILATOR SHUT DOWN WHEN AC WAS APPLIED. FURTHER TESTING REVEALED THE VOLTAGE WAS DROPPING BELOW THE THRESHOLD VOLTAGE, APPROXIMATELY 8.5 VOLTS, REQUIRED TO INITIALIZE U8. THE C56 CAPACITOR SIGNAL WAS DROPPING TO 7.72V. THE DETERMINATION COULD BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. THE ROOT CAUSE OF THE REPORTED FAILURE IS DUE TO THE VOLTAGE WAS DROPPING BELOW THE SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS DOWN. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED ISSUE WAS DISCOVERED BUT THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    THE MANUFACTURE'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE FOR 12.5K PREVENTATIVE MAINTENANCE (PM). THE FSE NOTICED WHEN THE UNIT WAS PLUGGED INTO THE A/C POWER, THE MAIN LED ON THE VENTILATOR WOULDN'T LIGHT UP. WHEN THE FSE TURNED THE UNIT ON WITH A/C PLUGGED IN, THE UNIT WOULD SAY CONNECTED TO BATTERY. THERE WAS NO PATIENT INVOLVEMENT DUE TO THE EVENT OCCURRED DURING SERVICING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706449 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1