BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE2000

    MDR report key: 19771611 · Received July 18, 2024

    Report

    Report Number
    1316463-2024-00086
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 18, 2024
    Manufacturer
    WELCH ALLYN INC
    Product Code
    NOU
    UDI-DI
    887761978201
    PMA / PMN Number
    K170037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT'S OXYGEN SATURATION LEVEL DROPPED FROM 96% TO 72% WHILE USING THE LIFE2000 DEVICE. THE EMERGENCY SERVICES WERE CALLED, AND THE PATIENT WAS HOSPITALIZED. THE PATIENT RECOVERED IN THE HOSPITAL AND RETURNED HOME ON (B)(6) 2024 ON A NASAL CANNULA AT 4LPM O2 AT REST, AND 5LPM WITH AMBULATION. NO DETAILS OF THE MEDICAL INTERVENTION PERFORMED DURING HOSPITALIZATION WERE PROVIDED. THERE WAS NO REPORT OF DEVICE MALFUNCTION OR CONCENTRATOR ISSUE. THE PATIENT IS A 61-YEAR-OLD FEMALE WITH RELEVANT MEDICAL HISTORY OF CHRONIC RESPIRATORY FAILURE WITH HYPOXIA AND STAGE 4 COPD. DURING FOLLOW-UP, IT WAS CONFIRMED THE EVENT OCCURRED IN THE EARLY EVENING (5PM), AND THE BAXTER CLINICAL SUPPORT SPECIALIST REMINDED THE PATIENT TO NOT USE THE DEVICE AT NIGHT, AS THE PRESCRIPTION STATES THE PATIENT SHOULD USE THE LIFE2000 DURING DAYTIME AND AMBULATION, AND THE BIPAP AT NIGHTTIME. THE DEVICE REMAINS WITH THE PATIENT, WHO WILL SLOWLY RESUME USE DURING PULMONARY REHABILITATION. THE LIFE2000 VENTILATION SYSTEM IS INTENDED TO PROVIDE CONTINUOUS OR INTERMITTENT VENTILATORY SUPPORT FOR THE CARE OF INDIVIDUALS WHO REQUIRE MECHANICAL VENTILATION. THE LIFE2000® VENTILATION SYSTEM CAN BE USED IN DIFFERENT CONFIGURATIONS OF OPERATION AS THE PATIENT¿S NEEDS CHANGE. IN EXTENDED RANGE CONFIGURATION, THE VENTILATOR IS CONNECTED TO THE COMPRESSOR WITH A BREATHE TECHNOLOGIES® OXYGEN HOSE TO ENABLE THE ACTIVITIES OF DAILY LIVING. OXYGEN DESATURATION IS A BELOW-NORMAL LEVEL OF OXYGEN IN THE BLOOD. NORMAL PULSE OXIMETER READINGS RANGE FROM 94 TO 100 PERCENT A VALUE UNDER 90 PERCENT IS CONSIDERED LOW. OXYGEN DESATURATION CAN BE CONTRIBUTED TO DISORDERS SUCH AS COPD, EMPHYSEMA, RESPIRATORY FAILURE, OR OTHER PULMONARY DISORDERS. TREATMENT TYPICALLY CONSISTS OF OXYGEN MEASUREMENT (VIA BLOOD TEST OR PULSE OXIMETRY) AND OXYGEN ADMINISTRATION. IN THIS EVENT, THE PATIENT¿S OXYGEN SATURATION LEVEL WAS NOTED TO BE CLINICALLY BELOW NORMAL RANGE (72%), REQUIRED HOSPITALIZATION. NO DETAILS OF THE TREATMENTS PERFORMED IN THE HOSPITAL WERE PROVIDED, HOWEVER, IT IS REASONABLE TO CONCLUDE THAT DURING HOSPITALIZATION THE PATIENT LIKELY RECEIVED MEDICAL AND/OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE OF A BODY STRUCTURE AND/OR TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION, CONCLUDING A SERIOUS INJURY OCCURRED. ADDITIONALLY, THERE WAS NO REPORT OF DEVICE MALFUNCTION. THE EXACT CAUSE IS UNDETERMINED AT THIS TIME; HOWEVER, IT CAN BE REASONABLY CONCLUDED THAT THE REPORTED EVENT WAS LIKELY DUE TO THE PATIENT'S MEDICAL CONDITION (STAGE 4 COPD, CHRONIC RESPIRATORY FAILURE) AND UNLIKELY CAUSED BY THE DEVICE ITSELF. THE DEVICE REMAINS WITH THE PATIENT WHO WILL RESUME USE AS ADVISED BY HER HEALTHCARE TEAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT'S OXYGEN SATURATION LEVEL DROPPED FROM 96% TO 72% WHILE USING THE LIFE2000 DEVICE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919131 LIFE2000 CONTINUOUS, VENTILATOR, HOME USE NOU WELCH ALLYN INC BT-20-0002 887761978201

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization