BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIWAZE

    MDR report key: 23358133 · Received October 22, 2025

    Report

    Report Number
    3016774528-2025-00003
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 13, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ABMRC LLC
    Product Code
    NHJ
    UDI-DI
    B9652037351818201130
    PMA / PMN Number
    K191912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) HEALTH HOSPICE AND HOME HEALTH CONTACTED ABMRC ON SEPTEMBER 23, 2025, TO REPORT AN INCIDENT INVOLVING A PATIENT USING THE BIWAZE COUGH DEVICE. ACCORDING TO THE COMPLAINT, THE DEVICE REPORTEDLY DID NOT TURN ON WHEN THE CAREGIVER ATTEMPTED TO USE IT AT THE PATIENT'S HOME. THE PATIENT IS A 70-YEAR-OLD MALE WHO WAS SUFFERING FROM NEUROSARCOIDOSIS, OBSTRUCTIVE SLEEP APNEA (OSA), PERIPHERAL ARTERY DISEASE, HYPERTENSION, AND DIABETES MELLITUS. THE PATIENT WAS ALSO PRESCRIBED BIPAP MACHINE AND SUPPLEMENTAL OXYGEN APART FROM BIWAZE COUGH MACHINE. ON (B)(6) 2025, THE CAREGIVER ATTEMPTED TO USE THE DEVICE; HOWEVER, IT DID NOT TURN ON. THE PATIENT'S CAREGIVER SUBSEQUENTLY UNPLUGGED THE DEVICE AND TRIED ANOTHER OUTLET, BUT THE DEVICE STILL DID NOT TURN ON. AS PER THE CAREGIVER'S REPORT, THE PATIENT BEGAN TO DESATURATE AT APPROXIMATELY 11:00 PM (LOCAL TIME) AND LATER EXPERIENCED CARDIAC ARREST AS WELL ON THE WAY TO THE HOSPITAL. HE WAS RESUSCITATED ON THE WAY BEFORE REACHING THE HOSPITAL FOR FURTHER TREATMENT. AFTER FEW DAYS THE PATIENT PASSED AWAY IN THE HOSPITAL. AT THIS TIME, THERE IS NO ALLEGATION OR EVIDENCE INDICATING THAT THE BIWAZE COUGH DEVICE CONTRIBUTED TO THE PATIENT'S DETERIORATION OR DEATH. THE DEVICE WAS NOT IN USE DURING THE EVENT. THEREFORE, BASED ON CURRENTLY AVAILABLE INFORMATION, NO CAUSAL RELATIONSHIP HAS BEEN ESTABLISHED BETWEEN THE DEVICE AND THE REPORTED DEATH. THE HME TESTED THE RETURNED DEVICE TO CONFIRM THAT IT SHOWED INTERMITTENT POWER-ON ISSUES. SUBSEQUENTLY, THE BIWAZE COUGH DEVICE WAS RETURNED TO ABMRC ON OCTOBER 3, 2025, FOR EVALUATION. UPON VISUAL INSPECTION, NO EXTERNAL DAMAGE WAS OBSERVED. DURING THE SUBSEQUENT POWER CYCLE TESTING, ABMRC NOTICED INTERMITTENT POWER ON ISSUES. BASED ON THE INVESTIGATION AND TESTING PERFORMED, IT IS CONCLUDED THAT THE DEVICE EXHIBITED INTERMITTENT POWER CONNECTION BEHAVIOR, RESULTING FROM POWER SWITCH COMPONENT FAILURE. THE ISSUE OF POWER SWITCH PART FAILURE HAS BEEN RARELY OBSERVED IN OUR SHIPPED DEVICES. THE COMPLAINT WILL CONTINUE TO BE MONITORED CLOSELY, AND IF ANY TREND IS IDENTIFIED APPROPRIATE MEASURES WILL BE IMPLEMENTED TO MITIGATE THE RECURRENCE.

    Description of Event or Problem · 0

    ON SEPTEMBER 23, 2025, (B)(6) HEALTH HOSPICE AND HOME HEALTH INFORMED ABMRC OF A PATIENT DEATH. IT WAS ALSO INFORMED THAT FEW DAYS PRIOR TO THAT THEY TRIED TO USE BIWAZE COUGH DEVICE WHICH DID NOT TURN ON. ACCORDING TO THE DISTRIBUTOR (HME), THE PATIENT IS A 70-YEAR-OLD MALE WHO WAS SUFFERING FROM NEUROSARCOIDOSIS, OBSTRUCTIVE SLEEP APNEA (OSA), PERIPHERAL ARTERY DISEASE, HYPERTENSION, AND DIABETES MELLITUS. THE PATIENT WAS ALSO PRESCRIBED BIPAP MACHINE AND SUPPLEMENTAL OXYGEN APART FROM BIWAZE COUGH MACHINE. ON (B)(6) 2025, AT APPROXIMATELY 9:45 PM (LOCAL TIME), THE PATIENT'S CAREGIVER ATTEMPTED TO USE THE BIWAZE COUGH DEVICE; HOWEVER, THE DEVICE DID NOT TURN ON. THE PATIENT'S CAREGIVER THEN UNPLUGGED AND RECONNECTED THE DEVICE AND ATTEMPTED TO POWER IT ON AGAIN, BUT THE DEVICE STILL WOULD NOT TURN ON. PER THE CAREGIVER'S REPORT, THE PATIENT BEGAN TO DESATURATE AT APPROXIMATELY 11:00 PM (LOCAL TIME) AND LATER EXPERIENCED CARDIAC ARREST AS WELL ON THE WAY TO THE HOSPITAL. HE WAS RESUSCITATED ON THE WAY BEFORE REACHING THE HOSPITAL FOR FURTHER TREATMENT. AFTER FEW DAYS THE PATIENT PASSED AWAY IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229370 BIWAZE BIWAZE COUGH NHJ ABMRC LLC 2037351818-20113 B9652037351818201130

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male