BEUDAMED
    FDA Adverse Event Death Summary report: N

    V60 VENTILATOR

    MDR report key: 2428730 · Received January 26, 2012

    Report

    Report Number
    2031642-2012-00038
    Event Type
    Death
    Date Received
    January 26, 2012
    Date of Event
    December 30, 2011
    Report Date
    January 3, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FOLLOWING: THE PATIENT WAS IN THE PALLIATIVE CARE UNIT ON NIV VIA MASK. THE RESPIRATORY THERAPIST (RT) HEARD AN ALARM IN THE PATIENT'S ROOM. THE CIRCUIT TUBING WAS REPORTED DISCONNECTED FROM THE MASK. THE PATIENT WAS EXPIRED. THEY ARE NOT SURE IF THE PATIENT DISCONNECTED IT OR NOT. THE PATIENT WAS A DNR, THEREFORE, THERE WAS NO EFFORT TO RESUSCITATE. THE PATIENT DID HAVE A HISTORY OF BREATHING ISSUES. THE PATIENT WAS BREATHING SPONTANEOUSLY AND THERE HAD BEEN ATTEMPTS TO WEAN HER WITHOUT SUCCESS. PER HOSPITAL PROTOCOL, THE MANUFACTURER'S SERVICE WAS CALLED TO VERIFY THE PERFORMANCE OF THE DEVICE AND ITS ALARMS. THE VENTILATOR WAS EVALUATED AND PERFORMANCE VERIFICATION TESTING COMPLETED. TESTS PASSED TO OPERATING SPECIFICATIONS INCLUDING ALARMS. UPON EVALUATION OF THE DEVICE, THE LOUDNESS OF THE AUDIBLE ALARM WAS FOUND SET TO A LEVEL OF 4. ALARM LOUDNESS RANGE IS 1 - 10. THE PALLIATIVE CARE UNIT HAS NO REMOTE ALARM CAPABILITY. AN INTERNAL INCIDENT REPORT WAS GENERATED AND THERE WERE NO PERFORMANCE ISSUES OF THE VENTILATOR IDENTIFIED AS A CAUSE OR CONTRIBUTOR TO THE PATIENT'S DEATH. THEY ACKNOWLEDGE THAT THE DEVICE DID ALARM APPROPRIATELY. THEY KNOW THE DEVICE ALARM WAS SET TO A LEVEL 4 OUT OF 10 BY THE USERS WHICH WILL BE FOLLOWED UP ON WITH THEIR INTERNAL PROCESSES, AS IT SEEMS THAT IT IS LIKELY THE REASON THAT THE ALARM WAS NOT HEARD WAS DUE TO THE LOCATION OF THE PATIENT, AND THE ALARM MAY NOT HAVE BEEN SET TO AN APPROPRIATE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death