BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1701424 · Received May 27, 2010

    Report

    Report Number
    2031642-2010-00113
    Event Type
    Death
    Date Received
    May 27, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 29, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIRECTOR OF RESPIRATORY CARE REPORTED THE FOLLOWING: PATIENT WAS MALE W/ FIBROTIC LUNG DISEASE AND WAS HARD TO VENTILATE AND REQUIRED HIGH VENTILATOR SETTINGS. THEY NEEDED TO KEEP ADJUSTING THE VENTILATOR SETTINGS INCLUDING RESPIRATORY RATE (RR), PEAK FLOWS, AND VOLUMES. DUE TO THE PATIENT'S HIGH RR, THEY TRIED TO MATCH THE PATIENT'S RR WITH THE VENTILATOR. HE WAS ON THE VENTILATOR FOR SEVERAL DAYS. THE VENTILATOR BEGAN ALARMING WITH LOW O2 SUPPLY ALARM THE MORNING OF (B) (6) 2010. PATIENT WAS BAGGED WHILE THE ALARM WAS CHECKED OUT. PATIENT'S FIO2 WAS INCREASED TO 100%. OXYGEN SATURATIONS WOULD VARY. HE HAD TROUBLE WITH O2 SATURATIONS BECAUSE OF HIS CONDITION. PATIENT WAS REMOVED FROM VENTILATOR AND PLACED ON ANOTHER. PATIENT WAS OK FOR A FEW HOURS AND 2ND VENTILATOR STARTED ALARMING WITH LOW O2 SUPPLY. PATIENT WAS REMOVED FROM VENT AND PLACED ON ANOTHER. THEY SUSPECTED THE O2 WALL SOURCE. THE HOSPITAL CONTACTED A CONTRACTOR AND PLANT OPERATIONS TO CHECK OUT THE WALL SOURCE. SHE COULD NOT BE SURE THAT THE VENTILATOR DID OR DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH, BUT PATIENT WAS VERY ILL. THE VENTILATOR WAS INSPECTED BY MANUFACTURER'S SERVICE TECHNICIAN WHO WAS UNABLE TO DUPLICATE THE REPORTED OCCURRENCE. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS 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 Death