BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2513281 · Received April 2, 2012

    Report

    Report Number
    2031642-2012-00132
    Event Type
    Injury
    Date Received
    April 2, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 9, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS OUT OF WARRANTY; CUSTOMER TO SERVICE AND PART REQUESTED FOR RETURN TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    RESPIRATORY THERAPY (RT) MANAGER REPORTED THE FOLLOWING INFORMATION: ON (B)(6) 2012, THE FEMALE PATIENT WITH CONGESTIVE HEART FAILURE (CHF) WAS INTUBATED TO STABILIZE HER FOR TRANSFER TO AN ACUTE FACILITY. THE PATIENT WAS GIVEN PARALYTICS FOR INTUBATION PURPOSES. AFTER INTUBATION THE PATIENT WAS CODED DUE TO CHF AND BAGGED WITH 100%. NO CHEST COMPRESSIONS WERE GIVEN DURING THE CODE. THE VENTILATOR WAS SET UP FOR USE AND A SHORT SELF TEST (SST) WAS PERFORMED WHICH WAS REPORTED AS PASSED. DURING BAGGING WITH 100% O2, THE PATIENT'S OXYGEN SATURATION WAS IN THE 90'S. WHEN THE PATIENT WAS PUT ON THE VENTILATOR, THE OXYGEN SATURATION DROPPED DOWN TO 88% AT 100% FIO2. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND AGAIN BAGGED MANUALLY AT 100% AND THE O2 SATURATION INCREASED BACK INTO THE 90'S. THE PATIENT WAS NOT PUT BACK ON THE VENTILATOR BUT WAS MANUALLY BAGGED UNTIL TRANSFER WITH NO FURTHER PROBLEM. THERE WAS NO PERMANENT PATIENT HARM. THE HOSPITAL BIOMEDICAL TECHNICIAN REPORTED HE PERFORMED AN EXTENDED SELF TEST (EST) WHICH FAILED INDICATING THERE WAS NO OXYGEN CONNECTED. THE BIOMEDICAL TECHNICIAN REPORTED UPON INSPECTION, HE FOUND A CONNECTOR ON THE SENSOR BOARD PARTIALLY DISLODGED. THE CONNECTOR IS USED TO ATTACH THE WIRING FROM THE OXYGEN SUPPLY PRESSURE SWITCH. THE DEVICE IS OUT OF WARRANTY AND THE BIOMEDICAL TECHNICIAN WAS RECOMMENDED TO ORDER THE SENSOR BOARD FOR REPLACEMENT TO COMPLETE THE REPAIR AND ADDRESS THE REPORTED PROBLEM. IF THE OXYGEN SUPPLY PRESSURE IS DETERMINED TO BE OUT OF SPECIFICATION, THE DEVICE WILL ALARM TO ALERT THE USER AND CONTINUE TO VENTILATE USING AN AIR SOURCE.

    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