BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFE2000 COMP 100WH, PACKAGED

    MDR report key: 17834659 · Received September 28, 2023

    Report

    Report Number
    1316463-2023-00217
    Event Type
    Death
    Date Received
    September 28, 2023
    Date of Event
    August 27, 2023
    Report Date
    October 20, 2023
    Manufacturer
    WELCH ALLYN INC
    Product Code
    BTI
    PMA / PMN Number
    K170037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ON THE NIGHT OF THE (B)(6) 2023, THE PATIENT WAS HAVING DIFFICULTIES USING HER LIFE2000 DEVICE AND INADVERTENTLY TURNED OFF HER OXYGEN CONCENTRATOR INSTEAD OF THE LIFE2000 COMPRESSOR DUE TO HER CONFUSION, RESULTING IN NO OXYGEN SUPPORT FOR AN EXTENDED PERIOD OF TIME. THE PATIENT'S HEALTHCARE ASSISTANT FOUND HER IN POOR CONDITIONS THE MORNING AFTER AND CALLED 911. THE PATIENT WAS TRANSFERRED TO THE (B)(6) HOSPITAL, WHERE SHE WAS INTUBATED, EXTUBATED ((B)(6) 2023) AND TRANSFERRED TO A HOSPICE, WHERE SHE PASSED AWAY A FEW DAYS LATER. THE PATIENT'S FAMILY COULD NOT CONFIRM IF SHE WAS USING THE LIFE2000 DEVICE OR HER OWN NASAL CANNULA AT THE TIME OF THE EVENT. THE PATIENT WAS A 78-YEAR-OLD FEMALE WITH RELEVANT MEDICAL HISTORY OF COPD, ATRIAL FIBRILLATION, EMPHYSEMA, CHRONIC RESPIRATORY FAILURE WITH HYPOXIA. THE PATIENT'S FAMILY ALSO NOTED THE PATIENT HAD SUFFERED A STROKE IN PAST, WHICH MADE HER INCREASINGLY CONFUSED, ESPECIALLY AT NIGHTTIME, AND THIS COULD HAVE BEEN THE CAUSE OF THIS UNFORTUNATE EVENT IN THEIR OPINION. THE LIFE2000 SYSTEM WILL BE RETURNED FOR INSPECTION. 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. IN THIS EVENT, THE ULTIMATE CAUSE OF THE PATIENT'S DEATH CANNOT BE DETERMINED, HOWEVER, IT IS REASONABLE TO CONCLUDE THAT THE REPORTED EVENT WAS LIKELY DUE TO USE ERROR AS REPORTED BY FAMILY (POSSIBLY CONTRIBUTED BY THE PATIENT'S INCREASED CONFUSION AS NOTED ABOVE DUE TO A PREVIOUS STOKE), AND PATHOPHYSIOLOGY OF PATIENT¿S MEDICAL CONDITIONS (CHRONIC RESPIRATORY FAILURE WITH HYPOXIA, COPD, EMPHYSEMA) AND NOT A MALFUNCTION OF THE DEVICE. AS REPORTED, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION NOR CONFIRMATION THAT THE PATIENT WAS UTILIZING THE LIFE2000 AT TIME OF THE EVENT, HOWEVER, THE LIFE2000 SYSTEM IS BEING RETURNED AND WILL BE INSPECTED. ANY ADDITIONAL AND RELEVANT INFORMATION IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    REVISED WITH THE RECEIPT OF DEVICE INSPECTION DETAILS: A DEVICE INSPECTION PERFORMED BY A HILLROM TECHNICIAN NOTED THAT THE RETURNED LIFE2000 COMPRESSOR AND VENTILATOR WERE TESTED WITH A KNOWN WELL-FUNCTIONING COMBO HOSE AND PATIENT CIRCUIT. NO ERROR MESSAGES NOR ALARMS WERE OBSERVED. BOTH THE COMPRESSOR AND THE VENTILATOR FUNCTIONED AS DESIGNED. NO DEVICE MALFUNCTION WAS FOUND. IN THIS EVENT, THE ULTIMATE CAUSE OF THE PATIENT'S DEATH CANNOT BE DETERMINED, HOWEVER, IT IS REASONABLE TO CONCLUDE THAT THE REPORTED EVENT WAS LIKELY DUE TO USE ERROR AS REPORTED BY FAMILY (POSSIBLY CONTRIBUTED BY THE PATIENT'S INCREASED CONFUSION AS NOTED ABOVE DUE TO A PREVIOUS STROKE), AND PATHOPHYSIOLOGY OF PATIENT¿S MEDICAL CONDITIONS (CHRONIC RESPIRATORY FAILURE WITH HYPOXIA, COPD, EMPHYSEMA) AND NOT A MALFUNCTION OF THE DEVICE. AS REPORTED, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION NOR CONFIRMATION THAT THE PATIENT WAS UTILIZING THE LIFE2000 AT TIME OF THE EVENT, AND THE INSPECTION CONCLUDED THE DEVICE FUNCTIONED AS DESIGNED, HOWEVER, IT CANNOT BE EXCLUDED THAT THE DEVICE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON THE NIGHT OF THE (B)(6) 2023, THE PATIENT WAS HAVING DIFFICULTIES USING HER LIFE2000 DEVICE AND INADVERTENTLY TURNED OFF HER OXYGEN CONCENTRATOR INSTEAD OF THE LIFE2000 COMPRESSOR DUE TO HER CONFUSION, RESULTING IN NO OXYGEN SUPPORT FOR AN EXTENDED PERIOD OF TIME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON THE NIGHT OF THE (B)(6) 2023, THE PATIENT WAS HAVING DIFFICULTIES USING HER LIFE2000 DEVICE AND INADVERTENTLY TURNED OFF HER OXYGEN CONCENTRATOR INSTEAD OF THE LIFE2000 COMPRESSOR DUE TO HER CONFUSION, RESULTING IN NO OXYGEN SUPPORT FOR AN EXTENDED PERIOD OF TIME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010279 LIFE2000 COMP 100WH, PACKAGED COMPRESSOR, AIR, PORTABLE BTI WELCH ALLYN INC BT-80-0008

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death