BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE2000

    MDR report key: 17868684 · Received October 4, 2023

    Report

    Report Number
    1316463-2023-00222
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 6, 2023
    Report Date
    June 11, 2024
    Manufacturer
    WELCH ALLYN INC
    Product Code
    NOU
    UDI-DI
    00887761978201
    PMA / PMN Number
    K170037
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE CONCENTRATOR FLOW METER BALL DROPS WHEN USED WITH THE LIFE2000 DEVICE. THERE WAS NO INJURY REPORTED, MEDICAL INTERVENTION WAS NOT REQUIRED, AND THERE WAS NO OXYGEN DESATURATION ASSOCIATED WITH THE REPORTED EVENT. THE BREATHE TECHNOLOGIES LIFE2000® VENTILATION SYSTEM IS INTENDED TO PROVIDE CONTINUOUS OR INTERMITTENT VENTILATORY SUPPORT FOR THE CARE OF INDIVIDUALS WHO REQUIRE MECHANICAL VENTILATION. 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. INFORMATION REVIEWED REASONABLY SUGGESTS THE CAUSE OF THE REPORTED DROP IN THE CONCENTRATOR FLOWMETER IS POSSIBLY RELATED TO A SYSTEM INTERACTION/MALFUNCTION BETWEEN THE LIFE2000 AND THIRD-PARTY VENDOR CONCENTRATOR LEADING TO OXYGEN FLOW FROM THE CONCENTRATOR FALLING BELOW THE PRESCRIBED LEVEL. IF THIS SYSTEM INTERACTION/MALFUNCTION WERE TO RECUR, IT IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS A CORRECTION TO THE PREVIOUSLY SUBMITTED MDR. FOLLOWING COMMUNICATION FROM THE FDA REGARDING INCORRECT/MISSING UDI NUMBERS, BAXTER REVIEWED THE SUBJECT MDR AND DETERMINED BRAND NAME, PRODUCT CODE, AND UDI CORRECTIONS WERE REQUIRED TO THIS MDR IN ALIGNMENT WITH THE GUDID.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CONCENTRATOR FLOW METER BALL DROPS WHEN USED WITH THE LIFE2000 DEVICE. THERE WAS NO INJURY REPORTED, MEDICAL INTERVENTION WAS NOT REQUIRED, OR DESATURATION ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4)..

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CONCENTRATOR FLOW METER BALL DROPS WHEN USED WITH THE LIFE2000 DEVICE. THERE WAS NO INJURY REPORTED, MEDICAL INTERVENTION WAS NOT REQUIRED, OR DESATURATION ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105155 LIFE2000 CONTINUOUS, VENTILATOR, HOME USE NOU WELCH ALLYN INC BT-20-0002 00887761978201
    2014317 LIFE2000 CONTINUOUS, VENTILATOR, HOME USE NOU WELCH ALLYN INC BT-20-0002 00887761978201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown