BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE2000 VENTILATOR PACKAGED

    MDR report key: 17817632 · Received September 26, 2023

    Report

    Report Number
    1316463-2023-00213
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 18, 2023
    Manufacturer
    WELCH ALLYN INC
    Product Code
    CBK
    PMA / PMN Number
    K170037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2023 UPDATE: THE LIFE2000 VENTILATOR AND COMPRESSOR, INCLUDING THE COMBO HOSE AND PATIENT CIRCUIT WERE RETURNED FOR INSPECTION. THERAPIES WERE RUN AT LOW, MEDIUM, AND HIGH ACTIVITY LEVELS AND NO ERROR MESSAGE OR ALARMS WERE OBSERVED. THE LIFE2000 VENTILATOR AND COMPRESSOR PERFORMED AS INTENDED WITH NO MALFUNCTION IDENTIFIED. THE CAUSE OF THE REPORTED EVENT WAS LIKELY RELATED TO THE PATIENT¿S COMPLEX MEDICAL HISTORY AND POSSIBLY AN INTOLERANCE TO LIFE2000 THERAPY, AND NOT CAUSED OR CONTRIBUTED BY A MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT FELT AIR TRAPPING SYMPTOMS WITH USE OF THE LIFE2000. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. SINCE THE PATIENT WAS TRAINED ON THE LIFE2000, HE HAS FELT TOO MUCH AIR GOING IN AND DIFFICULTY GETTING AIR OUT. THE TRAINER ADJUSTED THE DEVICE SETTINGS FOR COMFORT AND INITIALLY THE PATIENT TOLERATED THE CHANGE. PER THE PATIENT, HIS OXYGEN SATURATION, WHICH WAS NOT REPORTED, WAS HIGHER (MID-90¿S) DURING REHAB. AFTER THE LIFE2000 DEVICE SETTINGS WERE ADJUSTED, THE PATIENT LATER REPORTED HE FELT HE WAS BREATHING BETTER OFF THE LIFE2000 DEVICE. THE PATIENT ALSO REPORTED ELEVATED BLOOD PRESSURE (BP) AFTER USE OF THE LIFE2000 REQUIRING MEDICATION. THE PATIENT FEELS HIS BP CHANGES ARE DUE TO DIFFICULTY BREATHING ON THE DEVICE. THE PATIENT ALSO STATED THAT CARRYING AROUND THE DEVICE WEARS HIM OUT AND HE HAS BEEN USING HIS NASAL CANNULA FOR APPROXIMATELY TWO WEEKS. THE PATIENT STOPPED USING THE LIFE2000 AND HIS BP NORMALIZED TO BASELINE, AND HE IS NOT REQUIRING MEDICATION FOR REGULATION OF HIS BP. THE PATIENT HAS A MEDICAL HISTORY OF COPD, COR PULMONALE, PULMONARY HYPERTENSION, CHRONIC HYPOXEMIA, CHF, RIGHT-SIDED HEART FAILURE, SHORTNESS OF BREATH, 26% LUNG FUNCTION. THE PATIENT REPORTED HE WILL BE PLACED ON THE LUNG TRANSPLANT LIST SOON. THE BAXTER RESPIRATORY CLINICIAN ADVISED THE PATIENT TO CONTACT HIS HEALTHCARE TEAM (HCT) REGARDING THE REPORTED SYMPTOMS AND DIRECTION ON USE OF THE LIFE2000. THE PATIENT WILL CONTACT HIS HCT PRIOR TO A ANY DEVICE RETRAINING OR DEVICE SETTING ADJUSTMENTS. FOLLOW UP WITH THE PATIENT IS PLANNED BY THE BAXTER RESPIRATORY CLINICIAN. THE BAXTER RESPIRATORY CLINICIAN CONTACTED THE PATIENT WHO REQUESTED TO RETURN THE DEVICE DUE TO RECEIVING A LETTER THAT THE DEVICE WAS NOT APPROVED. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE PATIENT. PER THE PATIENT, THE "VALVES IN HIS LUNGS ARE SHOT" AND HE HAS AN APPOINTMENT TO DISCUSS BEING PLACED ON THE LUNG TRANSPLANT LIST. THE PATIENT STATED HE DOES NOT HAVE TROUBLE GETTING AIR INTO HIS LUNGS, BUT RATHER GETTING AIR OUT AND FELT THE DEVICE WAS BLOWING TOO MUCH AIR INTO HIS LUNGS EVEN AFTER THE DEVICE SETTINGS WERE LOWERED. THE PATIENT CHECKS HIS BLOOD PRESSURE (BP) AT NIGHT AND FOUND IT WAS ROUTINELY ELEVATED (159/95) WHILE USING THE LIFE2000. THE PATIENT HAS BEEN ON BLOOD PRESSURE MEDICATION PRIOR TO USE OF THE LIFE2000 AND HAS THE OPTION TO TAKE IT UP TO TWICE A DAY DEPENDING ON HIS BP READING. WHILE USING THE LIFE2000, THE PATIENT WAS TAKING HIS BLOOD PRESSURE MEDICATION AT NIGHT DUE TO HIGH BP AFTER USING THE LIFE2000. THE PATIENT STATED HE'S NOT SURE WHAT THE CAUSE OF THE ELEVATED BP WAS (EXHAUSTION FROM THE DEVICE, ANXIETY, ETC.), BUT HIS BP HAS NORMALIZED (SYSTOLIC OF 118) SINCE DISCONTINUING USE OF THE LIFE2000 AND HE NO LONGER TAKES MEDICATION AT NIGHT. NO ADDITIONAL INFORMATION 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 STATE ALWAYS HAVE AN ALTERNATE MEANS OF VENTILATION OR OXYGEN THERAPY AVAILABLE. HYPERTENSION IS A COMMON CONDITION THAT AFFECTS THE BODY¿S ARTERIES. RISK FACTORS FOR HYPERTENSION INCLUDE BUT ARE NOT LIMITED TO DIET, WEIGHT, AND AGE. ANXIETY CAN CAUSE DRAMATIC, TEMPORARY INCREASES IN BLOOD PRESSURE. TREATMENT CAN INCLUDE A COMBINATION OF DIET CHANGES, EXERCISE, AND MEDICATION. IN THIS EVENT, THE PATIENT¿S BLOOD PRESSURE BECAME ELEVATED WITH USE OF THE LIFE2000 DEVICE REQUIRING MEDICAL INTERVENTION (BLOOD PRESSURE MEDICATION) TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, WHICH CONCLUDES A SERIOUS INJURY OCCURRED. THE CAUSE OF THE EVENT IS UNDETERMINED. AN INSPECTION OF THE DEVICE IS PENDING, AND A MALFUNCTION CANNOT BE RULED OUT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELT AIR TRAPPING SYMPTOMS WITH USE OF THE LIFE2000. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. SINCE THE PATIENT WAS TRAINED ON THE LIFE2000, HE HAS FELT TOO MUCH AIR GOING IN AND DIFFICULTY GETTING AIR OUT. THE TRAINER ADJUSTED THE DEVICE SETTINGS FOR COMFORT AND INITIALLY THE PATIENT TOLERATED THE CHANGE. PER THE PATIENT, HIS OXYGEN SATURATION, WHICH WAS NOT REPORTED, WAS HIGHER (MID-90¿S) DURING REHAB. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELT AIR TRAPPING SYMPTOMS WITH USE OF THE LIFE2000. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. SINCE THE PATIENT WAS TRAINED ON THE LIFE2000, HE HAS FELT TOO MUCH AIR GOING IN AND DIFFICULTY GETTING AIR OUT. THE TRAINER ADJUSTED THE DEVICE SETTINGS FOR COMFORT AND INITIALLY THE PATIENT TOLERATED THE CHANGE. PER THE PATIENT, HIS OXYGEN SATURATION, WHICH WAS NOT REPORTED, WAS HIGHER (MID-90¿S) DURING REHAB. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831134 LIFE2000 VENTILATOR PACKAGED VENTILATOR, CONTINUOUS, FACILITY USE CBK WELCH ALLYN INC BT-20-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown