BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE2000 VENTILATOR PACKAGED

    MDR report key: 15709077 · Received November 1, 2022

    Report

    Report Number
    1316463-2022-00152
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 1, 2022
    Manufacturer
    WELCH ALLYN INC
    Product Code
    CBK
    PMA / PMN Number
    K170037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE HILLROM RESPIRATORY TRAINER THAT THE PATIENT¿S BLOOD PRESSURE (BP) INCREASED DURING INITIAL TRAINING ON THE LIFE2000 IN THE PATIENT¿S HOME. THE PATIENT IN THIS EVENT IS A 65-YEAR-OLD FEMALE WITH A MEDICAL HISTORY OF COPD, LATENT TUBERCULOSIS, CHRONIC HYPOXEMIC RESPIRATORY FAILURE, OBSTRUCTIVE SLEEP APNEA, SUPPLEMENTAL OXYGEN USE OF 3-4 LPM, SEVERE AIRWAY OBSTRUCTION ON PULMONARY FUNCTION TEST (PFT), AND HYPERTENSION FOR WHICH THE PATIENT HAS BEEN ON MEDICATION FOR MANY YEARS. PRIOR TO INITIATING TRAINING ON THE LIFE2000, THE TRAINER CHECKED THE PATIENT¿S BP AND SPO2; RESTING BP WAS 144/84 AND BASELINE SPO2 WAS 92% ON 4 LITERS OF OXYGEN. AFTER THE PATIENT AMBULATED ON REGULAR OXYGEN, HER SPO2 WAS 70-72% AND BP WAS 176/80. THE TRAINER THEN PLACED THE PATIENT ON THE LIFE2000 WITH 4 LITERS OF OXYGEN VIA AN OXYGEN CONCENTRATOR (MANUFACTURER UNKNOWN) AND THE PATIENT¿S BP INCREASED TO 194/103. THE TRAINER RECHECKED THE PATIENT¿S BP AND IT WAS 183/88. ON A PEEP OF 1, THE PATIENT¿S SPO2 DROPPED TO 72% AGAIN. ON HIGH ACTIVITY LEVEL AND 4 LITERS OF OXYGEN, THE PATIENT¿S BP WAS 211/107. THE TRAINER THEN TRIED THE PATIENT ON 5 LITERS OF OXYGEN AND PEEP OF 2. THE PATIENT¿S SPO2 DROPPED TO 80-83% WHILE AMBULATING AND DROPPED AS LOW AS 72% AFTER THE PATIENT SAT DOWN. DURING THIS TIME, THE PATIENT EXPERIENCED SEVERE SHORTNESS OF BREATH AND THE TRAINER BELIEVED THE PATIENT WAS HAVING A PANIC ATTACK. THE PATIENT¿S BP WAS 214/110 AT WHICH POINT TRAINING WAS STOPPED. THE PATIENT¿S BP DECREASED TO 166/92 AND SPO2 RECOVERED AFTER SWITCHING TO HER REGULAR OXYGEN. NO MEDICAL INTERVENTION WAS REQUIRED. PER THE TRAINER, NO DEVICE ALARMS OCCURRED DURING TRAINING AND THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE LIFE2000 WAS REMOVED FROM THE PATIENT¿S HOUSE BY THE TRAINER. DEVICE TRAINING WILL BE PERFORMED AGAIN AFTER THE PATIENT RECEIVES CLEARANCE FROM HER PHYSICIAN. 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. 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; HOWEVER, ANXIETY CAN CAUSE DRAMATIC, TEMPORARY INCREASES IN BLOOD PRESSURE. TREATMENT CAN INCLUDE A COMBINATION OF DIET CHANGES, EXERCISE, AND MEDICATION. 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, ALTHOUGH THE PATIENT¿S OXYGEN LEVEL WAS CLINICALLY BELOW NORMAL RANGE AND BLOOD PRESSURE WAS ABOVE NORMAL RANGE, THE CHANGE WAS TEMPORARY, AND MEDICAL INTERVENTION WAS NOT REQUIRED. ADDITIONALLY, THE PATIENT RECOVERED AT HOME BY STOPPING LIFE 2000 TRAINING AND SWITCHING TO THE ALREADY PRESCRIBED OXYGEN THERAPY, AND THERE WAS NO REPORT OF PERMANENT IMPAIRMENT OF BODY FUNCTION OR STRUCTURE, WHICH CONCLUDES/INDICATES NO SERIOUS INJURY OCCURRED. THE ULTIMATE CAUSE OF THE REPORTED DROP IN OXYGEN SATURATION IS UNKNOWN, AND LIKELY MULTIFACTORIAL DUE TO THE PATIENT'S UNDERLYING PULMONARY PATHOLOGY AND HYPERTENSION HISTORY. AT THIS TIME, AN INSPECTION OF THE DEVICE IS PENDING, THEREFORE, HILLROM IS UNABLE TO RULE OUT IF A SYSTEM INTERACTION/MALFUNCTION BETWEEN THE LIFE2000 AND THIRD-PARTY VENDOR OXYGEN CONCENTRATOR. IF FURTHER INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE UPDATED ACCORDINGLY. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED ON THE MANUFACTURER OF THE CONCENTRATOR USED AND THE COMPATIBILITY WITH THE DEVICE, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HILLROM RESPIRATORY TRAINER THAT THE PATIENT¿S BLOOD PRESSURE (BP) INCREASED DURING INITIAL TRAINING ON THE LIFE2000 IN THE PATIENT¿S HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511355 LIFE2000 VENTILATOR PACKAGED VENTILATOR, CONTINUOUS, FACILITY USE CBK WELCH ALLYN INC BT-20-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female