BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFE2000 VENTILATOR PACKAGED

    MDR report key: 16734230 · Received April 13, 2023

    Report

    Report Number
    1316463-2023-00067
    Event Type
    Death
    Date Received
    April 13, 2023
    Date of Event
    March 4, 2023
    Report Date
    April 13, 2023
    Manufacturer
    WELCH ALLYN INC.
    Product Code
    CBK
    PMA / PMN Number
    K170037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE PATIENT HAD BEEN SUFFERING FROM SHINGLES (LOCATED FROM HIS SHOULDERS TO HANDS), HAD A SETBACK AND WAS PLACED ON A HIGH-VOLUME DRIP WITH ANTIBIOTICS TO FIGHT THE INFECTION. THE PATIENT WAS A 73-YEAR-OLD MALE WITH A RELEVANT MEDICAL HISTORY OF HYPOXIA, COPD, PULMONARY FIBROSIS, ASTHMA, AND PULMONARY GRANULOMA. AT THE TIME OF THE EVENT THE LIFE 2000 WAS CONNECTED TO THE PATIENT¿S THIRD-PARTY CONCENTRATOR. THE PATIENT¿S WIFE STATES SHE NEVER NOTICED THE CONCENTRATOR BALL DROP WHILE CONNECTED TO THE VENTILATOR. SHE DID HOWEVER EXPLAIN THAT THE ¿PATIENT FEELS HE NEEDS A SETTING ADJUSTMENT ON THE VENTILATOR AND THAT IT JUST ISN¿T WORKING CORRECTLY.¿ MALFUNCTION WAS ALLEGED, AND THE VENTILATOR IN QUESTION WAS RETURNED TO HILLROM FOR INSPECTION. FOLLOW UP FROM THE TRAINER ON (B)(6) 2023 NOTED HE ¿DID NOT BELIEVE¿ THE PATIENT WAS ON THE DEVICE WHEN HE PASSED. IT WAS DETERMINED THE PATIENT HAD A SEVERE SHINGLES, CELLULITIS, AND DEVELOPED PNEUMONIA WHILE IN THE HOSPITAL DECREASING HIS HEALTH. MULTIPLE FOLLOW-UP ATTEMPTS HAVE BEEN MADE; HOWEVER, THE CUSTOMER HAS NOT PROVIDED ANY FURTHER DETAILS OF HOSPITAL ADMISSION (HYPOXIC EPISODE, SHINGLES, OR BOTH), CAUSE & DATE OF DEATH, CONFIRMATION ON IF THE PATIENT WAS USING THE DEVICE AT THE TIME OF DEATH, AND IF THE PATIENT HAD A HISTORY OF SHINGLES OR IF THIS WAS NEWLY DIAGNOSED WITH USE OF THE DEVICE. 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. INSPECTION OF THE DEVICE BY A HILLROM TECHNICIAN FOUND THE DEVICE WAS FUNCTIONING AS DESIGNED. HYPOXEMIA (LOW OXYGEN SATURATIONS) IS A BELOW-NORMAL LEVEL OF OXYGEN IN THE BLOOD, SPECIFICALLY IN THE ARTERIES. NORMAL ADULT BLOOD OXYGEN LEVELS TYPICALLY RANGE FROM 95 TO 100 PERCENT. OXYGEN DESATURATION CAN BE CONTRIBUTED TO DISORDERS SUCH AS RESPIRATORY FAILURE, RESPIRATORY INFECTIONS, OR OTHER PULMONARY DISORDERS. TREATMENT TYPICALLY CONSISTS OF OXYGEN MEASUREMENT (VIA BLOOD TEST OR PULSE OXIMETRY) AND OXYGEN ADMINISTRATION. SHINGLES IS A VIRAL INFECTION CAUSED BY VARICELLA-ZOSTER CHARACTERIZED BY A PAINFUL RASH WITH BLISTERS. RARE BUT SEVERE COMPLICATIONS INCLUDE PNEUMONIA, HEARING PROBLEMS, BLINDNESS, AND BRAIN INFLAMMATION. TREATMENT INCLUDES ANTIVIRAL AND PAIN MEDICATIONS. PNEUMONIA IS AN INFECTION THAT INFLAMES THE AIR SACS IN ONE OR BOTH THE LUNGS. PNEUMONIA CAN RANGE IN SERIOUSNESS FROM MILD TO LIFE-THREATENING. IT IS MOST SERIOUS FOR INFANTS AND YOUNG CHILDREN, PEOPLE OLDER THAN AGE 65, AND PEOPLE WITH HEALTH PROBLEMS OR WEAKENED IMMUNE SYSTEMS. IN THIS EVENT, INITIALLY THE PATIENT¿S OXYGEN LEVEL WAS CLINICALLY BELOW NORMAL RANGE, HE WAS ADMITTED TO THE HOSPITAL AND LATER EXPIRED. MULTIPLE FOLLOW-UP ATTEMPTS OCCURRED; HOWEVER, THE CUSTOMER¿S WIFE HAS NOT PROVIDED THE REASON OF THE HOSPITAL ADMISSION (HYPOXIC EPISODE, SHINGLES, OR BOTH), CAUSE OF DEATH, AND USE OF DEVICE AT THE TIME OF DEATH. ADDITIONALLY, THE ULTIMATE CAUSE OF THE INITIAL REPORTED DROP IN OXYGEN SATURATION IS UNKNOWN, AND LIKELY MULTIFACTORIAL DUE TO THE PATIENT'S UNDERLYING PULMONARY PATHOLOGY. HOWEVER, CURRENTLY HILLROM IS UNABLE TO RULE OUT IF A SYSTEM INTERACTION/ MALFUNCTION BETWEEN THE LIFE2000 AND THIRD-PARTY VENDOR CONCENTRATOR ATTRIBUTED TO THE DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 DURING IN-HOME THERAPY OF THE LIFE 2000 THE PATIENT¿S ¿OXYGEN SATURATION DROPPED TO THE 80¿S.¿ IT IS NOTED THE PATIENT SWITCHED TO HIS IN-HOME OXYGEN AND RECOVERED; HOWEVER, POST THE EVENT HIS WIFE ¿IMMEDIATELY DROVE TO THE ER¿ WHERE THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER EXPIRED. THIS EVENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095264 LIFE2000 VENTILATOR PACKAGED VENTILATOR, CONTINUOUS, FACILITY USE CBK WELCH ALLYN INC. BT-20-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death