BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE2000

    MDR report key: 19794104 · Received July 22, 2024

    Report

    Report Number
    1316463-2024-00087
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 22, 2024
    Manufacturer
    WELCH ALLYN INC
    Product Code
    NOU
    UDI-DI
    887761978201
    PMA / PMN Number
    K170037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2024, HER OXYGEN SATURATION WAS IN THE 50¿S WHEN SHE WOKE UP. THE PATIENT IS A 70-YEAR-OLD FEMALE WITH A MEDICAL HISTORY OF CHRONIC RESPIRATORY FAILURE WITH HYPERCAPNIA, COPD, HYPERTENSION, AND PANLOBULAR EMPHYSEMA. AT THE TIME OF THE REPORTED EVENT, THE PATIENT WAS USING THE LIFE2000 VENTILATOR AND COMPRESSOR, AND DEVILBISS HOME OXYGEN CONCENTRATOR SET AT 3 LPM. THERE WERE NO ALARMS NOTED ON THE LIFE2000 OR OXYGEN CONCENTRATOR, AND NO MALFUNCTION OF EITHER DEVICE WAS REPORTED. THE DAUGHTER SWITCHED THE PATIENT TO A NASAL CANNULA AND THE PATIENT¿S SPO2 INCREASED TO THE 60'S. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED, AND THE PATIENT¿S SPO2 INCREASED TO THE 70¿S IN THE AMBULANCE AND INTO THE 80¿S UPON ARRIVAL AT THE HOSPITAL. THE PATIENT STATED SHE WAS HOSPITALIZED BECAUSE HER OXYGEN SATURATION WAS LOW AND WOULD NOT GO UP (ADMITTING DIAGNOSIS UNKNOWN). TREATMENT INCLUDED BREATHING TREATMENTS, CORTISONE, IN ADDITION TO OTHER TREATMENT THE PATIENT COULD NOT RECALL. THE PATIENT WAS DISCHARGED HOME AFTER 5 DAYS AND WAS FEELING WELL. THE PATIENT HAS NOT USED THE LIFE2000 SINCE AND IT WAS DETERMINED THAT THE LIFE2000 DID NOT MEET HER RESPIRATORY NEEDS AS IT DOES NOT GO HIGH ENOUGH. THE PATIENT WAS CURRENTLY ON 3.5 LPM OF OXYGEN VIA NASAL CANNULA. PATIENT STATED SHE HAS A NEW HOME OXYGEN CONCENTRATOR (MANUFACTURER UNKNOWN) BUT HAS NOT BEEN PRESCRIBED ANOTHER NON-INVASIVE VENTILATION DEVICE. THERE WAS NO ISSUE WITH THE DEVILBISS CONCENTRATOR; THE NEW CONCENTRATOR WAS MEDICARE APPROVED FOR HER SUPPLEMENTAL OXYGEN NEEDS AND EQUIPMENT. THE LIFE2000 DEVICE IS SCHEDULED FOR PICK UP. THE LIFE2000 VENTILATION SYSTEM IS INTENDED TO PROVIDE CONTINUOUS OR INTERMITTENT VENTILATORY SUPPORT FOR THE CARE OF INDIVIDUALS WHO REQUIRE MECHANICAL VENTILATION. THE SYSTEM IS INTENDED FOR USE BY QUALIFIED, TRAINED PERSONNEL UNDER THE DIRECTION OF A PHYSICIAN. SPECIFICALLY, THE SYSTEM IS APPLICABLE FOR ADULT PATIENTS WHO REQUIRE THE FOLLOWING TYPES OF VENTILATORY SUPPORT: POSITIVE PRESSURE VENTILATION, DELIVERED INVASIVELY (VIA ET TUBE) OR NON-INVASIVELY (VIA MASK); ASSIST/CONTROL MODE OF VENTILATION. THE DEVICE INSTRUCTION FOR USE (IFU) STATE ALWAYS HAVE AN ALTERNATE MEANS OF VENTILATION OR OXYGEN THERAPY AVAILABLE. 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. IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED OXYGEN DESATURATION WITH AN OXYGEN SATURATION TO THE 50'S AND REQUIRED MEDICAL INTERVENTION INCLUDING HOSPITALIZATION WITH TREATMENT TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, CONCLUDING A SERIOUS INJURY OCCURRED. THE ULTIMATE CAUSE TO THE DESATURATION IS UNDETERMINED. THE INSPECTION OF THE LIFE 2000 DEVICE (WITH THE PATIENT'S SUBMITTED COMBO HOSE AND PATIENT CIRCUIT) NOTES THAT 3 LPM OF OXYGEN FROM A EVERFLO RESPIRONICS 5 LITTER OXYGEN CONCENTRATOR WAS BLED IN, THERAPIES WERE RUN AT LOW, MEDIUM, AND HIGH ACTIVITY LEVELS AND NO ALARMS WERE OBSERVED, AND NO ERROR MESSAGE WERE RECEIVED. THE INSPECTION FOUND NO MALFUNCTION OF THE DEVICE AND THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT ON (B)(6) 2024, HER OXYGEN SATURATION WAS IN THE 50¿S WHEN SHE WOKE UP. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979947 LIFE2000 CONTINUOUS, VENTILATOR, HOME USE NOU WELCH ALLYN INC BT-20-0002 887761978201

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization