BiPAP AVAPS 00 (REF 1167P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00606959039261), received between Aug 30, 2021 and Dec 9, 2025 — classified as 2 deaths, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Degraded” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K102465); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A HOSPITAL ALLEGING A VENTILATOR ALARM OCCURRED AND DEVICE STILL DID NOT OPERATE AFTER ADJUSTMENT. THERE WAS NO PATIENT HARM OR INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. GOOD FAITH EFFORTS ARE ACTIVELY BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED FOR EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760782 ↗
• MalfunctionOct 2, 2024Degraded; Degraded

  THIS COMPLAINT HAS BEEN REVIEWED FOR THE INFORMATION THE MANUFACTURER RECEIVED "THE UNIT STOPPED AFTER UNO" AND WILL BE REPORTED AS A PRODUCT PROBLEM. ALTHOUGH THERE WAS NO PATIENT HARM OR INJURY, AS THE EVENTS DO NOT MEET THE DEFINITION OF A REPORTABLE SERIOUS INJURY COMPLAINT PER THE FDA REGULATIONS (21 CFR 803) THIS EVENT IS REPORTABLE BECAUSE THE FAILURE COULD AFFECT THE ABILITY OF THE DEVICE TO PROVIDE THERAPY TO PUBLISHED SPECIFICATIONS. A REPORT WILL BE FILED WITH ALL APPLICABLE REGULATORY AGENCIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349748 ↗
• MalfunctionMar 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR CRITICAL ERROR OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. NO MEDICAL INTERVENTIONS WERE SPECIFIED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE LOG CONFIRMED THE ALLEGATION. THE DEVICE'S MAIN PCA WAS REPLACED TO REPAIR THE DEVICE. THE DEVICE PASSED ALL TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960242 ↗
• MalfunctionFeb 22, 2024Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS STOPPED WORKING. 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 18758943 ↗
• MalfunctionDec 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR POWER CORD WAS SMOKING AND BURNT. THERE WAS NO HARM OR INJURY REPORTED. 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 18322888 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A 67-YEAR-OLD PATIENT SUFFERING FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE RECEIVED A DIAGNOSIS OF A LUNG MASS FOLLOWING THE USE OF A VENTILATOR. IT WAS REPORTED THAT THE MASS IN THE LUNGS FOR THE PATIENT WAS NINETY PERCENT (90%) LUNG CANCER AND REACHED A SIZE OF THREE TO FIVE CENTIMETERS (3-5 CM). NO ADDITIONAL CLINICAL INFORMATION OR MEDICAL INTERVENTION HAS BEEN SPECIFIED AT THIS TIME. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cancer

  MAUDE report 18140283 ↗
• MalfunctionMar 15, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND OBSERVE REPLACED MAIN PCA AND HUMID BASE CABLE DURING DEVICE EVALUATION THERE WAS NO ALLEGATION OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771965 ↗
• MalfunctionOct 28, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713086 ↗
• DeathSep 16, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO DEVELOP FUNGAL INFECTION. THE PATIENT HAS REPORTEDLY HOSPITALIZED IN RESPONSE TO THE EVENT AND HAS SINCE DIED. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Pulmonary Emphysema

  MAUDE report 12485060 ↗
• DeathAug 30, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED. THE PATIENT EXPIRED IN (B)(6) 2021. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Insufficient Information

  MAUDE report 12388129 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102465. One submission often covers many models, so check the product and lot details in each record.

• 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 Respiron