BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2743759 · Received September 13, 2012

    Report

    Report Number
    2031642-2012-00398
    Event Type
    Injury
    Date Received
    September 13, 2012
    Date of Event
    August 29, 2012
    Report Date
    August 30, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE QUARANTINED.

    Description of Event or Problem · 1

    THE HOSPITAL CEO CONTACTED THE DEVICE MANUFACTURER REGARDING MANUFACTURER REQUEST FOR ADDITIONAL EVENT INFORMATION. THE HOSPITAL CEO REPORTED THAT SHE WILL NEED TO CONSULT WITH HOSPITAL LEGAL COUNSEL BEFORE PROVIDING ANY INFORMATION ON THE EVENT. SHE SAID SHE IS UNAWARE OF THE DETAILS OF THE EVENT, OR IF THEY HAVE BEEN ABLE TO DETERMINE WHAT THE ROOT CAUSE OF THE EVENT OCCURRENCE WAS. SHE STATED SHE WOULD CALL BACK ONCE SHE DISCUSSES THE EVENT WITH OTHERS. THE DEVICE MANUFACTURER HAS RECEIVED NO FOLLOWUP OR RESPONSES TO MULTIPLE CALLS AND VOICE MAIL MESSAGES FOR FURTHER INFORMATION REGARDING REPORTED PATIENT INJURY AND OUTCOME.

    Description of Event or Problem · 1

    THE HOSPITAL CEO CONTACTED THE DEVICE MANUFACTURER AND REPORTED SHE WAS ADVISED BY THE HOSPITAL LEGAL COUNSEL NOT TO RELEASE ANY INFORMATION, AND IF AUTHORITIES HAVE ANY QUESTIONS THEY CAN CONTACT HER DIRECTLY.

    Description of Event or Problem · 1

    THE CARDIOPULMONARY DIRECTOR REPORTED THE VENTILATOR WAS TURNED OFF BY AN UNKNOWN SOURCE WHILE IT WAS IN USE ON A PATIENT. THE CARDIOPULMONARY DIRECTOR REPORTED THE RESPIRATORY THERAPIST STATED THE VENTILATOR WAS FOUND WITH THE POWER SWITCH IN THE OFF POSITION. THE PATIENT WAS REMOVED FROM THE DEVICE AND THE HOSPITAL STAFF INITIATED A CODE RESPONSE. THE PATIENT WAS MOVED TO ICU. THE DEVICE WAS REMOVED FROM SERVICE AND QUARANTINED PENDING HOSPITAL ASSESSMENT. THE CARDIOPULMONARY DIRECTOR WOULD PROVIDE NO FURTHER INFORMATION AND REFERRED MANUFACTURER TO THE HOSPITAL COO FOR MORE INFORMATION. MULTIPLE ATTEMPTS MADE TO OBTAIN FURTHER INFORMATION OF THE EVENT FROM THE HOSPITAL COO WITH NO RESPONSES RECEIVED.

    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