BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFE2000 VENTILATOR PACKAGED

    MDR report key: 17574242 · Received August 18, 2023

    Report

    Report Number
    1316463-2023-00182
    Event Type
    Death
    Date Received
    August 18, 2023
    Date of Event
    July 21, 2023
    Report Date
    September 27, 2023
    Manufacturer
    WELCH ALLYN INC
    Product Code
    CBK
    UDI-DI
    00887761978201
    PMA / PMN Number
    K170037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE PATIENT¿S DAUGHTER THAT THEY ARE HAVING TROUBLE KEEPING THE PATIENT¿S OXYGEN SATURATION UP AS IT DROPS QUICKLY WHEN THE PATIENT GETS UP TO MOVE AROUND. THE PATIENT IS A 74-YEAR-OLD MALE WITH A MEDICAL HISTORY OF PULMONARY FIBROSIS. THE PATIENT WAS TRAINED AND INITIATED THERAPY ON THE LIFE2000 ON (B)(6) 2022. HE HAS USED THE DEVICE THROUGHOUT THE DAY AND NIGHT SINCE INITIAL SET-UP AS THE PATIENT REPORTEDLY DOES NOT DO WELL ON OXYGEN ALONE. ON (B)(6) 2023, THE RESPIRATORY TRAINER ADJUSTED THE DEVICE SETTINGS, WHICH THE DAUGHTER STATED WAS HELPFUL AT THE TIME, BUT THEY ARE NOW USING THE HIGHEST ACTIVITY LEVEL ALL THE TIME AND THE DAUGHTER IS UNSURE WHAT TO DO. DURING PHYSICAL THERAPY, THE PATIENT DESATURATED INTO THE 70¿S WHEN HE STOPPED THE SESSION EARLY TO USE THE BATHROOM. THE DAUGHTER STATED THE PATIENT¿S DISEASE IS PROGRESSING, AND HE IS NEEDING MORE SUPPORT AND REQUESTED ANOTHER TITRATION. DURING THIS CALL WITH THE BAXTER RESPIRATORY CLINICIAN, THE PATIENT¿S SATURATIONS WERE 94% AT REST ON 6.5 LPM OF OXYGEN ON THE HIGH ACTIVITY LEVEL. PLAN: RESPIRATORY TRAINER TO PERFORM A HOME VISIT TO DO ANOTHER TITRATION. PATIENT TO CONTINUE USING THE LIFE2000 AND MONITOR OXYGEN SATURATION DURING ACTIVITY. UPON ARRIVAL OF THE RESPIRATORY TRAINER AT THE PATIENT¿S HOME ON (B)(6) 2023, THE PATIENT WAS ON THE LIFE2000 HIGH ACTIVITY SETTING. THE PATIENT¿S SPO2 AT REST WAS 94% WITH NO SIGNS OF DISTRESS OR SHORTNESS OF BREATH (SOB) NOTED. THE TRAINER NOTED THE PATIENT TENDS TO BREATHE THROUGH HIS MOUTH AND THE NASAL PILLOWS DRIFT OUT OF HIS NOSE AND THE DAUGHTER WAS ADVISED THAT THIS COULD CAUSE HIS SPO2 TO DROP. THE DAUGHTER STATED SHE WAS AWARE, AND THEY REMIND THE PATIENT OF THIS FREQUENTLY. THE PATIENT FINDS IT EASIER TO BREATHE THROUGH HIS MOUTH ESPECIALLY WHEN HE IS FEELING SOB WITH ACTIVITY. THE TRAINER ADVISED OF A MASK OPTION, WHICH WOULD REQUIRE A PRESCRIPTION FROM THE PROVIDER. THE DEVICE SETTINGS WERE ADJUSTED BY THE RESPIRATORY TRAINER, AND THE PATIENT¿S SPO2 WAS 96% AT THE END OF THE VISIT. ADDITIONALLY, THE TRAINER NOTED THE COMPRESSOR SOUNDED LOUDER THAN NORMAL AND THE PATIENT WAS GIVEN A NEW COMPRESSOR. ON (B)(6) 2023, THE RESPIRATORY CLINICIAN SPOKE WITH THE PATIENT¿S DAUGHTER WHO INFORMED THAT THE PATIENT DIED ON (B)(6) 2023. THE DAUGHTER STATED SHE WENT TO VISIT AND FOUND THE PATIENT LYING IN BED WITH THE INTERFACE NEXT TO HIM AND THE LIFE2000 RUNNING. THE DAUGHTER THOUGHT HE MAY HAVE GOTTEN UP IN THE MIDDLE OF THE NIGHT TO USE THE BATHROOM. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THE LIFE2000 VENTILATION SYSTEM IS INTENDED TO PROVIDE CONTINUOUS OR INTERMITTENT VENTILATORY SUPPORT FOR THE CARE OF INDIVIDUALS WHO REQUIRE MECHANICAL VENTILATION. THE DEVICE INSTRUCTION FOR USE NOTE THE FOLLOWING WARNING: IF THE BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM IS NOT FUNCTIONING PROPERLY, RESPIRATORY THERAPY MAY BE COMPROMISED AND MAY RESULT IN PATIENT HARM OR DEATH. 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. IN THIS EVENT, THE PATIENT¿S CAUSE OF DEATH WAS UNKNOWN. PER THE PATIENT¿S DAUGHTER, THE PATIENT¿S DISEASE WAS PROGRESSING, AND THE PATIENT WAS HAVING DIFFICULTY MAINTAINING AN APPROPRIATE SPO2 WITH ACTIVITY. ADDITIONALLY, IT WAS NOTED BY THE RESPIRATORY TRAINER AND DAUGHTER THAT THE PATIENT WAS BREATHING THROUGH HIS MOUTH AND THE NASAL PILLOWS DRIFTED OUT OF HIS NOSE, WHICH COULD CAUSE A DECREASED SPO2. AN INSPECTION OF THE DEVICE IS PENDING. IT CAN REASONABLY BE CONCLUDED THAT THE PATIENT¿S MEDICAL HISTORY AND DISEASE PROGRESSION WERE KEY FACTORS IN HIS DEATH, HOWEVER, THE LIFE2000 WAS IN USE AT THE TIME OF THE EVENT AND A DEVICE MALFUNCTION CANNOT BE RULED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP WAS PERFORMED WITH THE PATIENT¿S DAUGHTER WHO REPORTED SHE ARRIVED AT HER FATHER¿S HOUSE AT APPROXIMATELY 06:30 ON (B)(6) 2023. THE DAUGHTER TURNED OFF THE LIFE2000 VENTILATOR, COMPRESSOR, AND THIRD-PARTY OXYGEN CONCENTRATOR AFTER FINDING HER FATHER DECEASED. FURTHER INVESTIGATION OF THE REPORTED EVENT WAS COMPLETED. THE LIFE2000 VENTILATOR AND (2) COMPRESSORS USED BY THE PATIENT WERE RECEIVED FOR INSPECTION AND SET UP IN AN EXTENDED RANGE CONFIGURATION USING A KNOWN GOOD COMBO HOSE AND PATIENT CIRCUIT. THERAPIES WERE RUN AT LOW, MEDIUM, AND HIGH ACTIVITY LEVELS. THE VENTILATOR AND COMPRESSORS FUNCTIONED AS INTENDED. A REVIEW OF THE DEVICE EVENT HISTORY WAS PERFORMED, AND LOW PIP ALARMS (PEAK INSPIRATORY PRESSURE BELOW SET LIMIT) WERE NOTED TO HAVE OCCURRED STARTING AT 03:17 ON (B)(6) 2023. MULTIPLE LOW PIP ALARMS WERE GENERATED AND CLEARED IN THE HOURS PRECEDING THE DAUGHTER FINDING THE PATIENT DECEASED. THE LAST LOW PIP ALARM OCCURRED AT 04:07 AND THE LIFE2000 WAS POWERED OFF AT 06:02. IT IS UNKNOWN WHAT OCCURRED IN THE 2-HOUR PERIOD BETWEEN THE LAST LOW PIP ALARM AND THE DEVICE BEING POWERED OFF BY THE PATIENT¿S DAUGHTER. THE DEVICE INSTRUCTIONS FOR USE STATE WHEN A LOW PIP ALARM OCCURS, ENSURE THE PATIENT INTERFACE IS NOT LEAKING AT THE PATIENT SIDE, ENSURE THE VENTILATOR IS PROPERLY DOCKED INTO THE COMPRESSOR, CHECK INTERFACE CONNECTIONS, AND REPLACE THE INTERFACE IF IT IS LEAKING. THE EXACT SEQUENCE OF EVENTS THAT OCCURRED IS UNKNOWN, HOWEVER, PER THE DAUGHTER¿S REPORT, IT HAD APPEARED THE PATIENT REMOVED THE NASAL INTERFACE. UPON REVIEW OF THE PATTERN OF LOW PIP ALARMS GENERATED BY THE DEVICE BETWEEN 3:17 AND 4:07, IT IS POSSIBLE THAT UPON REMOVAL OF THE NASAL INTERFACE BY THE PATIENT, AN EXTERNAL RESISTANCE WAS CREATED BETWEEN THE PATIENT AND/OR BEDDING THAT MAY HAVE INHIBITED THE DEVICE¿S NEED TO GENERATE ADDITIONAL LOW PIP ALARMS. AFTER REVIEW OF THE INVESTIGATION FINDINGS, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED, AND IT IS UNKNOWN IF THE LIFE2000 DEVICE CONTRIBUTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT¿S DAUGHTER THAT THEY ARE HAVING TROUBLE KEEPING THE PATIENT¿S OXYGEN SATURATION UP AS IT DROPS QUICKLY WHEN THE PATIENT GETS UP TO MOVE AROUND.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT¿S DAUGHTER THAT THEY ARE HAVING TROUBLE KEEPING THE PATIENT¿S OXYGEN SATURATION UP AS IT DROPS QUICKLY WHEN THE PATIENT GETS UP TO MOVE AROUND. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340413 LIFE2000 VENTILATOR PACKAGED VENTILATOR, CONTINUOUS, FACILITY USE CBK WELCH ALLYN INC BT-20-0002 00887761978201

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Death