BiPAP V30 Auto BiPAP V30 Auto, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00606959067936), received between Aug 22, 2024 and Apr 3, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K113053); they may or may not involve this specific model.

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.

Recalls naming this device

1. Aug 26, 2022Class IOpen, Classified

   Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

   Z-1656-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A VENTILATOR INOPERATIVE CONDITION WAS REPORTED ON A BIPAP A30 DEVICE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN (B)(4) DUE TO INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. GOOD FAITH EFFORTS ARE ACTIVELY BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781364 ↗
• InjuryNov 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO THE MANUFACTURER BY A DISTRIBUTOR THAT THE BIPAP V30 AUTO DEVICE CEASED FUNCTIONING DURING ACTIVE THERAPY ON A PATIENT IN THE HOSPITAL/USER FACILITY. THE PATIENT WAS ADMITTED WITH ACUTE ON CHRONIC HYPOXIC AND HYPERCAPNIC RESPIRATORY FAILURE AND WAS PLACED ON THE BIPAP V30 AUTO AT SETTINGS OF S/T 10/5 CMH2O WITH 6 L/MIN OXYGEN BLEED-IN AT APPROXIMATELY 00:58. ABOUT ONE HOUR AFTER THERAPY INITIATION, THE DEVICE SHUT OFF AND DISPLAYED A ¿VENTILATOR INOPERATIVE¿ CONDITION. BASED ON AVAILABLE INFORMATION, THE DEVICE ENTERED AN INOPERATIVE CONDITION DURING USE, RESULTING IN A VENTILATION INTERRUPTION. THIS CONTRIBUTED TO PATIENT DESATURATION AND SUBSEQUENT HYPERCAPNIA REQUIRING INTUBATION. THE EVENT HAS BEEN ASSESSED AS A SERIOUS INJURY PER 21 CFR 803.3(W). THE DEVICE CAUSE/CONTRIBUTION TO THE EVENT IS CONFIRMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND IS CURRENTLY AWAITING EVALUATION. SHOULD THE DEVICE BE RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED TO PROVIDE THE INVESTIGATION RESULTS.

  Patient problems: Hypoxia

  MAUDE report 23507282 ↗
• MalfunctionAug 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP V30 AUTO, DOMESTIC DEVICE ALARMED FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY ALLEGED. THE DEVICE HAS YET TO BE RETURNED FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737604 ↗
• MalfunctionOct 28, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20548115 ↗
• MalfunctionOct 28, 2024Degraded; Appropriate Device Problem Term/Code Not Available; Degraded; Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE CLINICAL ASSESSMENT STATES THAT BASED ON THE INFORMATION CURRENTLY PROVIDED AND AVAILABLE, NO HARM OR INJURY HAS BEEN SUSTAINED AND THEREFORE FURTHER ANALYSIS OF CAUSE AND/OR CONTRIBUTION OF THE DEVICE TO A SERIOUS INJURY OR DEATH IS NOT APPLICABLE. THE REPORTER NOTES PRE-EXISTING CONDITIONS OF: RESPIRATORY FAILURE, COPD/ASTHMA OR OTHER CHRONIC LUNG DISEASE, HISTORY OF MYOCARDIAL INFARCTION OR CARDIAC ARREST, CONGESTIVE HEART FAILURE, CHRONIC OXYGEN DEPENDENCY. BASED UPON THE INFORMATION PROVIDED, THESE CONDITIONS HAVE BEEN REVIEWED AND ASSESSED AS UNRELATED TO THE DEVICE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546107 ↗
• MalfunctionAug 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043027 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113053. One submission often covers many models, so check the product and lot details in each record.

• Z-2036-2025 · May 9, 2025 · Open, Classified
  BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide n
• Z-1654-2022 · Aug 26, 2022 · Open, Classified
  Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
• Z-1958-2021 · Jun 14, 2021 · Open, Classified
  A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
• Z-1973-2021 · Jun 14, 2021 · Open, Classified
  DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironic
• Z-1957-2021 · Jun 14, 2021 · Open, Classified
  A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use