BiPAP AVAPS. BiPAP AVAPS C Series Core Pack w/Heated Tube, 30cm, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00606959012592), received between May 11, 2022 and Jun 11, 2026 — classified as 7 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Degraded” (26 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Degraded

  A BIPAP AVAPS DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF VISIBLE FOAM PARTICLES WAS FOUND. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED LOOSE POWER CONNECTOR AND DUST CONTAMINATION, AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479821 ↗
• MalfunctionFeb 6, 2026Degraded

  A BIPAP AVAPS DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM PARTICLES WAS FOUND INSIDE THE BLOWER KIT AND BLOWER FOAM DEGRADATION. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION, FLUID FAIL AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITION AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279066 ↗
• MalfunctionFeb 5, 2026Degraded

  A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER 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 DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION AND DUST CONTAMINATION. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE HAS BEEN SCRAPPED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270362 ↗
• MalfunctionFeb 4, 2026Degraded

  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. A BIPAP AVAPS C SERIES DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS FOUND INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION, AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256663 ↗
• MalfunctionFeb 2, 2026Degraded

  A BIPAP AVAPS DEVICE WAS RETURNED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240363 ↗
• MalfunctionSep 10, 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 COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180825 ↗
• MalfunctionAug 14, 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 WAS 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 COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984280 ↗
• MalfunctionAug 9, 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 AN ISSUE RELATED TO A BIPAP AVAPS DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT 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 COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953558 ↗
• InjuryAug 9, 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 KIDNEY DISEASE/TOXICITY AND LUNG DISEASE. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Unspecified Kidney or Urinary Problem; Unspecified Respiratory Problem

  MAUDE report 19950476 ↗
• MalfunctionJul 5, 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 AN ISSUE RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THE PATIENT REPORTED EYE IRRITATION. THERE WAS NO HARM OR INJURY REPORTED. DUE TO POTENTIAL LITIGATION SURROUNDING THIS CASE, NO FOLLOW UP CAN BE PERFORMED AT THIS TIME. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Eye Irritation

  MAUDE report 19679662 ↗
• InjuryJul 3, 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 AN ISSUE RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THE PATIENT REPORTED CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED BY THE PATIENT. DUE TO POTENTIAL LITIGATION SURROUNDING THIS CASE, NO FOLLOW UP CAN BE PERFORMED AT THIS TIME. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Cancer

  MAUDE report 19666176 ↗
• InjuryMay 24, 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 NOSE IRRITATION, INFLAMMATORY RESPONSE, LUNG DISEASE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Inflammation; Unspecified Respiratory Problem

  MAUDE report 19392594 ↗
• InjuryMay 22, 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 EYE, NOSE, SKIN, RESPIRATORY IRRITATIONS, LIVER DISEASE, AND TOXICITY. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Asthma; Eye Irritation; Liver Damage/Dysfunction; Sinusitis; Skin Inflammation/ Irritation; Unspecified Respiratory Problem

  MAUDE report 19371059 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 KIDNEY DISEASE/TOXICITY, AND COPD. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Unspecified Kidney or Urinary Problem

  MAUDE report 19201475 ↗
• MalfunctionApr 4, 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 SPECIFIED AS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043503 ↗
• InjuryMar 13, 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 NOSE IRRITATION, OTHER, NODULE ON LEFT LUNG, ACUTE RESPIRATORY FAILURE, AND PNEUMONIA. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Nodule; Pneumonia; Respiratory Failure; Skin Inflammation/ Irritation

  MAUDE report 18893986 ↗
• MalfunctionJan 4, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  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 RESPIRATORY TRACT IRRITATION. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18447384 ↗
• MalfunctionSep 19, 2023Degraded; 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 COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17776919 ↗
• InjuryAug 9, 2023Degraded; 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 LUNG DISEASE AND DIFFICULTY BREATHING/SHORT OF BREATH. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Dyspnea; Unspecified Respiratory Problem

  MAUDE report 17487318 ↗
• MalfunctionNov 8, 2022Degraded; 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO DIFFICULTY BREATHING/SHORT OF BREATH.THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Dyspnea

  MAUDE report 15753292 ↗
• MalfunctionNov 7, 2022Degraded; 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. 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 15743709 ↗
• MalfunctionOct 4, 2022Degraded; 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 AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO HAVING HEADACHE.THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Headache

  MAUDE report 15538656 ↗
• MalfunctionSep 30, 2022Degraded; 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 DIFFICULTY BREATHING/SHORT OF BREATH. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Dyspnea

  MAUDE report 15510681 ↗
• MalfunctionJun 8, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Dizziness; Eye Irritation; Headache; No Clinical Signs, Symptoms or Conditions; Unspecified Respiratory Problem

  MAUDE report 14634950 ↗
• MalfunctionMay 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 14489453 ↗

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 Respironic