BiWaze Cough 203735181820113Recalls & reported problems
Abmrc LLC · This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients and paediatric patients 3 years old and up. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B9652037351818201130), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Power Up” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up1
Patient problems
- Discomfort1
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Failure to Power Up; Failure to Power Up
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.
Patient problems: Discomfort; Low Oxygen Saturation
MAUDE report 23358133 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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