BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE2000 VENTILATOR PACKAGED

    MDR report key: 17565057 · Received August 17, 2023

    Report

    Report Number
    1316463-2023-00181
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 17, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT WHEN THE CUSTOMER ATTEMPTED TO PRESS THE LOW ACTIVITY SETTINGS, THE LIFE2000 VENTILATOR ALARMED AND DISPLAYED "DISCONNECT OXYGEN". THE PATIENT'S HUSBAND NOTED THIS WAS THE FIRST TIME THE DEVICE DISPLAYED THIS MESSAGE, AND THAT IT USUALLY DISPLAYS "CONNECT OXYGEN". HE STATED HE PRESSED YES ANYWAY AND IT SEEMED THAT THE DEVICE WAS WORKING WELL. HOWEVER, THE PATIENT'S SPO2 LEVEL RANGED BETWEEN 70% AND 90% THROUGHOUT THE NIGHT, AND THE PATIENT WOKE UP FEELING "VERY ILL" AND HER STOMACH WAS EXTREMELY BLOATED. THE PATIENT WAS SWITCHED TO HER TRILOGY VENTILATOR AND HER OXYGEN SATURATION LEVEL RETURNED TO THE EXPECTED RANGE, HER STOMACH ALSO RECOVERED. MEDICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT IS A 80-YEAR-OLD FEMALE WITH RELEVANT MEDICAL HISTORY OF CHRONIC RESPIRATORY FAILURE WITH HYPOXIA, COPD, HYPOTHYROIDISM, ANAEMIA, PARAPLEGIA, CHF, GERD AND ATELECTASIS. THE PATIENT'S HUSBAND STATED THAT ALL CONNECTIONS WERE CORRECT, NO KINKED TUBING, AND BALL DROP ON THE CONCENTRATOR WAS OBSERVED. THE TRAINER REPLACED THE DEVICE VENTILATOR TO RESOLVE THE ISSUE AND THE PATIENT RESUMED THE USE OF THE DEVICE WITH NO FURTHER COMPLICATION. THE REPLACED VENTILATOR WAS 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. 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, IT WAS REPORTED THAT THE PATIENT¿S OXYGEN LEVEL WAS CLINICALLY BELOW NORMAL RANGE THROUGHOUT THE NIGHT (BETWEEN 70% AND 90%), AND THE PATIENT RECOVERED IN THE MORNING BY SWITCHING THE OXYGEN SUPPLY TO HER TRILOGY VENTILATOR. HOWEVER, THE EVENT OF OXYGEN DESATURATION ACCOMPANIED BY THE PATIENT FEELING "VERY ILL" AND THE BLOATED STOMACH IS CONSIDERED LIFE-THREATENING, CONCLUDING A SERIOUS INJURY OCCURRED. ADDITIONALLY, THE DEVICE VENTILATOR WAS REPLACED AND THE LIFE2000 SYSTEM FUNCTIONED AS DESIGNED. THE PATIENT HAS RESUMED THE USE OF THE DEVICE WITH NO FURTHER COMPLICATION REPORTED. THE PREVIOUSLY REPLACED VENTILATOR WILL BE RETURNED FOR INSPECTION. INVESTIGATION IS ONGOING, ALL ADDITIONAL AND RELEVANT INFORMATION IDENTIFIED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE CUSTOMER ATTEMPTED TO PRESS THE LOW ACTIVITY SETTINGS, THE LIFE2000 VENTILATOR ALARMED AND DISPLAYED "DISCONNECT OXYGEN". THE PATIENT'S HUSBAND NOTED THIS WAS THE FIRST TIME THE DEVICE DISPLAYED THIS MESSAGE, AND THAT IT USUALLY DISPLAYS "CONNECT OXYGEN". HE STATED HE PRESSED YES ANYWAY AND IT SEEMED THAT THE DEVICE WAS WORKING WELL. HOWEVER, THE PATIENT'S SPO2 LEVEL RANGED BETWEEN 70% AND 90% THROUGHOUT THE NIGHT, AND THE PATIENT WOKE UP FEELING "VERY ILL" AND HER STOMACH WAS EXTREMELY BLOATED. THE PATIENT WAS SWITCHED TO HER TRILOGY VENTILATOR AND HER OXYGEN SATURATION LEVEL RETURNED TO THE EXPECTED RANGE, HER STOMACH ALSO RECOVERED. MEDICAL INTERVENTION WAS NOT REQUIRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736467 LIFE2000 VENTILATOR PACKAGED VENTILATOR, CONTINUOUS, FACILITY USE CBK WELCH ALLYN INC BT-20-0002 00887761978201

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other