REMstar System One 60 Series REMstar Pro C-Flex+ w/HT Humid, BTOOTH Sys One 60 Srs, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00606959030121), received between Feb 1, 2022 and Jan 28, 2026 — classified as 15 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Degraded” (90 reports).

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 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Degraded

  A REMSTAR PRO C-FLEX+ DEVICE WAS RETURNED TO A THIRD-PARTYS SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET BLOWER FOAM DEGRADATION WAS NOTED. THE DEVICE'S SOUND ABATEMENT FOAM NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202742 ↗
• MalfunctionJan 28, 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 24201073 ↗
• MalfunctionJan 8, 2026Degraded

  A REMSTAR PRO CFLEX DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE THE SERVICE TECHNICIAN OBSERVED NO FOAM PARTICLES IN THE AIRPATH YET FOAM DEGRADATION WAS NOTED THE DEVICES SOUND ABATEMENT FOAM NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED ERROR CODES E53 ERRCOMPLOGSEMTIMEOUT E3 ERRINTRAM AND E124 ERRPREFETCHEXCEPTION AND DUST FAIL CONTAMINATION THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006914 ↗
• MalfunctionDec 30, 2025Degraded; Degraded

  A REMSTAR PRO C-FLEX+ DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM DEGRADATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930446 ↗
• InjuryDec 27, 2025Adverse 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 THAT THE REPORTER EXPERIENCED MULTIPLE ONGOING AND SEVERE HEALTH ISSUES WHILE USING THE PHILIPS CPAP DEVICE, INCLUDING LUNG AND RESPIRATORY PROBLEMS, WAKING UP COUGHING AND VOMITING WHICH LED TO HOSPITALIZATION. LATER THE PATIENT COLLAPSED DUE TO BRONCHOSPASMS AND WAS PLACED IN A MEDICALLY INDUCED COMA. IN (B)(6) 2022, THE REPORTER WAS HOSPITALIZED AGAIN WITH MULTIPLE HEALTH ISSUES AND WAS DIAGNOSED WITH MAST CELL ACTIVATION SYNDROME, CAUSING SEVERE NERVE REACTIONS AND HYPERSENSITIVITY. THE REPORTER HAS DEVELOPED SEVERE ALLERGIES TO A WIDE RANGE OF TRIGGERS, INCLUDING ANIMALS AND FOOD. THE REPORTER NOW CARRIES SEVERAL EPIPENS AT ALL TIMES AND CANNOT VISIT FAMILY MEMBERS WITH PETS DUE TO RISK OF SEVERE REACTIONS. EATING AND WORKING HAVE BECOME DIFFICULT, RESULTING IN SIGNIFICANT WEIGHT LOSS AND JOB LOSS (PREVIOUSLY EMPLOYED AS A DRAFTSPERSON). ACCORDING TO INFORMATION PRESENTED AFTER SEVERAL YEARS OF USING THE DEVICE, THE REPORTER EXPERIENCES

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Confusion/ Disorientation; Cough; Dyspnea; Memory Loss/Impairment; Nausea; Pulmonary Dysfunction; Rash; Upper Respiratory Tract Irritation; Vomiting

  MAUDE report 23901540 ↗
• MalfunctionNov 25, 2025Contamination; Degraded; Contamination; 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 VISUALIZATION OF PARTICLES IN DEVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN CONFIRMED PARTICLES IN THE AIR PATH DURING THE DEVICE EVALUATION. DURING THE DEVICE EVALUATION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DUST LIKE CONTAMINATIONS WAS OBSERVED. THERE WAS NO ERROR CODE FOUND. THE DEVICE WAS CORRECTED. DURING THE EVALUATION SECONDARY FINDINGS WAS OBSERVED. COMPLAINT WAS CONFIRMED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644646 ↗
• MalfunctionNov 24, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630324 ↗
• MalfunctionNov 24, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS WAS AND FLUID OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629284 ↗
• MalfunctionNov 24, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS 1 ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629179 ↗
• MalfunctionNov 24, 2025Degraded; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS 2 ERRORS CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629102 ↗
• MalfunctionNov 24, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE 2 ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629084 ↗
• MalfunctionNov 24, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS AND DUST CONTAMINATION WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS ZERO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628553 ↗
• MalfunctionNov 24, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS VISIBLE FOAM DEGRADATION. THE UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628291 ↗
• MalfunctionNov 23, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS 5 ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628082 ↗
• MalfunctionNov 21, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS VISIBLE FOAM DEGRADATION. THE UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614897 ↗
• MalfunctionNov 21, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS AND DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS ONE ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE COMPLAINT AND THERE WERE VISIBLE FOAM DEGRADATION AND UNIT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614172 ↗
• MalfunctionNov 20, 2025Degraded; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS TWO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603344 ↗
• MalfunctionNov 20, 2025Contamination; Degraded; Contamination; Degraded

  THE 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION, DUST. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS ONE ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WERE VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23601589 ↗
• MalfunctionNov 19, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS THREE ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592526 ↗
• MalfunctionNov 18, 2025Contamination; Degraded; Contamination; Degraded

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION INSIDE THE BLOWER KIT. DURING THE EVALUATION, SECONDARY FINDINGS WAS OBSERVED, AND DUST CONTAMINATION WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS SIX ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581008 ↗
• MalfunctionNov 3, 2025Degraded; Overheating of Device; Degraded; Overheating of Device

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, BURNT POWER CONNECTOR WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS 3 ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WERE NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452144 ↗
• MalfunctionNov 3, 2025Degraded; Overheating of Device; Degraded; Overheating of Device

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, BURNT POWER CONNECTOR WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS ONE ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449253 ↗
• MalfunctionNov 3, 2025Degraded; Overheating of Device; Degraded; Overheating of Device

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, BURNT POWER CONNECTOR WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS THREE ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WERE NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448255 ↗
• MalfunctionNov 3, 2025Contamination; Degraded; Overheating of Device; Contamination; Degraded; Overheating of Device

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, BURNT POWER CONNECTOR WAS OBSERVED AND SECONDARY FINDINGS DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS THREE ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447629 ↗
• MalfunctionNov 3, 2025Degraded; Overheating of Device; Degraded; Overheating of Device

  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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, BURNT POWER CONNECTOR WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS 19 ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447362 ↗