BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE2000 VENTILATOR PACKAGED

    MDR report key: 17343950 · Received July 18, 2023

    Report

    Report Number
    1316463-2023-00164
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 18, 2023
    Manufacturer
    WELCH ALLYN INC
    Product Code
    CBK
    UDI-DI
    00887761978201
    PMA / PMN Number
    K170037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INITIALLY REPORTED THAT PATIENT APPEARED PALE AND SWEATY WHILE USING THE LIFE2000 SYSTEM IN COMBINATION WITH 4LPM O2 VIA OXYGEN CONCENTRATOR. HER SPO2 WAS REPORTED TO BE 87% AT THAT TIME, THE PATIENT'S DAUGHTER SWITCHED THE OXYGEN SUPPLY TO THE OXYGEN TANK AND THE PATIENT RECOVERED IN FEW MINUTES (95%). THE DAY AFTER THIS EVENT WAS REPORTED, THE TRAINER PERFORMED TITRATION OF THE SYSTEM, ADVISED HIGH CARE PLAN SETTINGS AND MADE SURE THE PATIENT KEPT HER SPO2 LEVELS ABOVE 90%. THE DEVICE COMPRESSOR AND THE VENTILATOR WERE REPLACED FOR THE CUSTOMER AS THEY WERE DUE FOR PREVENTATIVE MAINTENANCE. THE TRAINER ALSO SECURED THE DEVICE'S INTERFACE TO THE PATIENT'S BACK OF THE HEAD TO PREVENT IT FROM FALLING. THE DAY AFTER THE TRAINER'S VISIT, THE PATIENT'S DAUGHTER REPORTED A SECOND EVENT OF DESATURATION (SPO2 55%) OCCURRED WHEN SWITCHING THE PATIENT O2 SUPPLY FROM HER TRILOGY VENTILATOR TO THE LIFE2000 SYSTEM. THE O2 SUPPLY WAS AGAIN SWITCHED TO THE OXYGEN TANK AND THE PATIENT RECOVERED (SPO2 95%). NO ACCOMPANYING SIGNS OR SYMPTOMS WERE REPORTED WITH THIS SECOND EVENT. THE PATIENT IS A 79-YEAR-OLD FEMALE WITH RELEVANT MEDICAL HISTORY OF CHRONIC RESPIRATORY FAILURE AND COPD. IT WAS ALSO REPORTED THAT THE PATIENT'S DAUGHTER BELIEVED THE DEVICE COMBO HOSE HAD AN AIR LEAK. THE COMBO HOSE WAS REPLACED, AND THE ISSUE RESOLVED AS THE PATIENT IS MAINTAINING BASELINE SPO2 LEVELS (ABOVE 90%) WHILE USING THE DEVICE. THE PREVIOUSLY REPLACED DEVICE VENTILATOR IS BEING RETURNED FOR FURTHER 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. THE COMBO2® HOSE MAY BE USED TO CONNECT THE LIFE2000® VENTILATION SYSTEM IN EXTENDED RANGE CONFIGURATION AND PROVIDE SUPPLEMENTAL LOW-FLOW OXYGEN FROM AN OXYGEN CONCENTRATOR OR OTHER LOW-FLOW OXYGEN SOURCE. THE LIFE2000 USER MANUAL STATES: "VISUALLY INSPECT THE COMBO2®HOSE BEFORE USING IT, DURING USE IN EXTENDED RANGE CONFIGURATION, THE SOURCE GAS SUPPLY HOSE SHOULD REMAIN CONNECTED TO THE VENTILATOR AT ALL TIMES, EXCEPT WHEN REQUIRED TO BE DISCONNECTED FOR MAINTENANCE, TESTING, OR REPLACEMENT". IN THE MAINTENANCE SECTION (DAILY CHECKS) THE USER MANUAL ALSO STATES: "CHECK THE INTERFACE AND THE SOURCE GAS SUPPLY HOSE (IF APPLICABLE) FOR LEAKS AND LOOSE OR DAMAGED CABLING OR CONNECTORS." 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 OXYGEN LEVEL WAS CLINICALLY BELOW NORMAL RANGE IN TWO OCCASIONS IN 2 DAYS (87%-55%), THE CHANGE WAS TEMPORARY, AND THE PATIENT RECOVERED AT HOME BY SWITCHING THE PATIENT'S O2 SUPPLY TO HER OWN OXYGEN TANK. HOWEVER, THE EVENT OF OXYGEN DESATURATION ACCOMPANIED BY THE PATIENT BEING PALE AND SWEATY IS CONSIDERED LIFE-THREATENING, CONCLUDING A SERIOUS INJURY OCCURRED. ADDITIONALLY, THE DEVICE COMBO HOSE WAS REPORTED TO HAVE AN AIR LEAK, ONCE THE COMBO HOSE WAS REPLACED, THE LIFE2000 SYSTEM FUNCTIONED AS DESIGNED. THE DEVICE IFU WARNS USERS TO VISUALLY INSPECT THE COMBO HOSE BEFORE USE AND CHECK FOR LEAKS OR LOOSE CONNECTORS, THEREFORE USE ERROR CANNOT BE EXCLUDED. THE PATIENT HAS RESUMED THE USE OF THE DEVICE WITH NO FURTHER COMPLICATION REPORTED. THE PREVIOUSLY REPLACED VENTILATOR WILL BE RETURNED FOR INVESTIGATION, IF ANY ADDITIONAL AND RELEVANT INFORMATION WILL BE RECEIVED, THE CASE WILL BE RE-ASSESSED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT PATIENT APPEARED PALE AND SWEATY WHILE USING THE LIFE2000 SYSTEM IN COMBINATION WITH 4LPM O2 VIA OXYGEN CONCENTRATOR. HER SPO2 WAS REPORTED TO BE 87% AT THAT TIME, THE PATIENT'S DAUGHTER SWITCHED THE OXYGEN SUPPLY TO THE OXYGEN TANK AND THE PATIENT RECOVERED IN FEW MINUTES (95%). THE DAY AFTER THIS EVENT WAS REPORTED, THE TRAINER PERFORMED TITRATION OF THE SYSTEM, ADVISED HIGH CARE PLAN SETTINGS AND MADE SURE THE PATIENT KEPT HER SPO2 LEVELS ABOVE 90%. THE DEVICE COMPRESSOR AND THE VENTILATOR WERE REPLACED FOR THE CUSTOMER AS THEY WERE DUE FOR PREVENTATIVE MAINTENANCE. THE TRAINER ALSO SECURED THE DEVICE'S INTERFACE TO THE PATIENT'S BACK OF THE HEAD TO PREVENT IT FROM FALLING. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142863 LIFE2000 VENTILATOR PACKAGED VENTILATOR, CONTINUOUS, FACILITY USE CBK WELCH ALLYN INC BT-20-0002 00887761978201

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other