BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1693311 · Received May 18, 2010

    Report

    Report Number
    2031642-2010-00090
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL RISK MANAGER REPORTED THE FOLLOWING: NURSE HEARD THE VENTILATOR ALARMING AND ENTERED THE ROOM. THE NURSE DID NOT HAVE ANY INFORMATION REGARDING THAT ANYTHING WAS BEING DONE WITH THE PATIENT. THE NURSE REPORTED THE FEMALE PATIENT WAS GRAY, THE VENTILATOR SCREEN WAS BLANK EXCEPT FOR TEXT 'VENT INOP' ON THE SCREEN, THE PATIENT'S CHEST WAS NOT RISING AND THE VENTILATOR WAS NOT CYCLING, AND THE VENTILATOR WAS ALARMING VERY LOUDLY. SHE DIDN'T NOTICE IF LEDS ON THE MONITOR PANEL WERE LIT. CODE WAS CALLED, CPR STARTED AND CODE TEAM RESPONDED. PHYSICIAN ARRIVED. TIME OF EVENT (CODE CALLED) 4/19 AT 1620. CPR FORM @ 1620 REPORTED: ATRIAL FIB RHYTHM NOTED. BP 131/75, HR 110. BAGGED @ 100%. AT 1623 RETURN OF CIRCULATION WITH RAPID ATRIAL FIB. PLACED BACK ON VENT VT 500, FIO2 100%, PEEP 5. BP 106/69, HEART RATE IRREGULAR 80-150 BPM. EARLIER THAT DAY AT APPROX. 1243 THE PATIENT'S O2 SATURATION DECREASED TO 79%. 1MINUTE LATER AT 1244 IT INCREASED TO 98%. THE PATIENT WAS UNDERGOING HEMODIALYSIS. VENT FLOWSHEET INFO @ 1247: CMV, RR SET 14, PT RR 42, VT 500, ACT VT 560, PIP 38, PF 65, PEEP 5, FIO2 28%, SPO2 92, HR 79, MV 18.9. RIGHT LUNG SOUNDS, DECREASED RIGHT & LEFT. VENT ALARMS CHECKED. PULSE OXIMETER WAS IN USE. POST CPR THE PATIENT WAS ALERT AND RESPONSIVE AS BEFORE CPR WAS STARTED. THE PATIENT WAS TRANSFERRED BUT IS RETURNING BACK TO THEIR FACILITY AND IS DOING FINE WITHOUT PERMANENT HARM. REVIEW OF THE VENTILATOR DIAGNOSTIC LOG INDICATED AN AIR SOURCE FAULT AND OXYGEN VALVE STUCK CLOSED OCCURRENCE. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE OCCURRENCE. INITIAL TESTING OF THE VENTILATOR PASSED. THE SERVICE TECHNICIAN REPLACED THE MAIN PCB BOARD, POWER SUPPLY AND BLOWER MOTOR CONTROLLER PCB BOARD AS A PRECAUTION. FINAL PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED TO 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 Required Intervention