BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3819138 · Received May 19, 2014

    Report

    Report Number
    2031642-2014-00350
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 6, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL BY 3RD PARTY SERVICE GROUP. NO RESULTS MADE AVAILABLE.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REQUEST INFORMATION REGARDING REMOTE ALARM USAGE AND REPORTED THERE WAS A PATIENT EVENT WHILE ON THE VENTILATOR. THE CUSTOMER REPORTED THE VENTILATOR WAS FROM A RENTAL AGENCY. THE CUSTOMER INITIALLY REFUSED TO PROVIDE ANY EVENT INFORMATION AND CALLS TO OBTAIN INFORMATION WERE FORWARDED ON TO HOSPITAL STAFF WHO ALSO WOULD NOT PROVIDE INFORMATION. THE FACILITY CHIEF CLINICAL ENGINEER REPORTED THE UNIT HAD BEEN EVALUATED BUT PROVIDED NOTHING FURTHER. THE DIRECTOR OF QUALITY WAS REACHED AND REPORTED THE FOLLOWING: 'ON (B)(6) 2014 AT 3:30AM THE PATIENT WAS FOUND UNRESPONSIVE, CYANOTIC, AND THE VENTILATOR WAS ALARMING. THE RESPONDING RESPIRATORY THERAPIST SAID THE EXPIRATORY LIMB OF THE PATIENT CIRCUIT WAS FOUND DISCONNECTED AT THE WYE. THE PATIENT WAS TRANSFERRED TO ICU. THERE WAS A RESPIRONICS (B)(4) REMOTE ALARM IN USE AT THE TIME OF THE EVENT. THE STAFF SAID THEY HEARD THE REMOTE ALARM SOUNDING. THE PATIENT IS FUNCTIONING AT A LOWER LEVEL.' THE DIRECTOR OF QUALITY STATED AFTER MUCH INTERNAL INVESTIGATION THE CUSTOMER DOES NOT BELIEVE THE VENTILATOR MALFUNCTIONED. THE UNIT REMAINS SEQUESTERED AND WAS EVALUATED BY A 3RD PARTY SERVICE ORGANIZATION. DEVICE EVALUATION RESULTS HAVE BEEN REQUESTED FROM 3RD PARTY SERVICE GROUP WITH NO INFORMATION RECEIVED TO DATE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM 3RD PARTY REPORTED DEVICE EVALUATION AND TESTING WAS PERFORMED TO MANUFACTURER SPECIFICATIONS AND NO FAILURES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296267 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR RESPIRONICS 34003 REMOTE ALARM