Breas Vivo 40 System USRecalls & reported problems
Breas Medical AB · Continuous ventilator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07321822010002), received between Sep 23, 2021 and Sep 23, 2021 — classified as 1 death.
The most frequently reported specific device problem is “Battery Problem” (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 16, 2026.
Most reported problems
Device problems
- Battery Problem1
- Use of Device Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathSep 23, 2021Use of Device Problem; Battery Problem
PATIENT WITH ALS HAS HAD SEVERAL BIPAP VENTILATORS SINCE (B)(6) 2015. ON THE EVENING (B)(6) 2017 THE PATIENT NOTIFIED THE HOMECARE PROVIDER. WHEN THEY ARRIVED THE PATIENT WAS DECEASED. THE HOSPITAL'S INVESTIGATION SHOWED THAT BIPAP (VIVO 40) WAS FUNCTIONING BUT THE BATTERY WAS DISCHARGED. IT WAS ALSO NOTED THAT THE POWER CABLE WAS NOT FULLY INSERTED INTO THE DEVICE. THE INCIDENT RESULTED IN AN LEXMARIA NOTIFICATION AND LANDSTINGENT I VARMLAND CONDUCTED AN INVESTIGATION. (DATED (B)(6) 2018, (B)(4)). THE LOG FILES WERE INVESTIGATED THE DEVICE GAVE AUDIBLE AND VISUAL ALARM AS DESIGNED. THE ROOT CAUSE COULD NOT BE ESTABLISHED. POSSIBLE SCENARIOS ACCORDING TO THE CUSTOMERS INVESTIGATION IS: USE ERROR OR PRODUCT MALFUNCTION. BREAS WAS NOTIFIED OF THE INCIDENT (B)(6) 2019, MORE THAN A YEAR AFTER THE INCIDENT. BREAS HAS NOT HAD ANY ACCESS TO THE DEVICE OR LOG FILES AND NO INVESTIGATION HAS BEEN PERFORMED. INFORMATION IN THE INVESTIGATIONS DONE BY THE CUSTOMER AND LANDSTINGENT I VARMLAND INDICATE THE DEVICE ACTED AS DESIGNED.
Patient problems: Insufficient Information
MAUDE report 12518791 ↗
Other Ventilator, Continuous, Minimal Ventilatory Support,Facility Use devices
- Philips Respironics V60Respironics California, Inc. · Ventilator, Continuous, Minimal Ventilatory Support,Facility Use3 recalls30 deaths13,525 reports
- PHILIPS 1076716Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death2,946 reports
- PHILIPS 1076709Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use8 deaths2,174 reports
- PHILIPS 1053614Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls4 deaths1,203 reports
- BiPAP A40 EEX3100S19Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls422 reports
- BiPAP A40 DEX3100S13Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls164 reports
- BiPAP A40 ITX3100S21Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls163 reports
- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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