DreamStation DreamStation BiPAP autoSV w/Humidifier, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00606959424401), received between Aug 13, 2024 and Mar 2, 2026 — classified as 1 death, 7 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Degraded” (62 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Degraded

  A DEVICE WAS RETURNED TO 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 NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WERE A VISIBLE FOAM DEGRADATION AND UNIT WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482036 ↗
• MalfunctionFeb 23, 2026Degraded

  A DEVICE WAS RETURNED TO 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 NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS A VISIBLE FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411984 ↗
• MalfunctionFeb 19, 2026Degraded

  A DEVICE WAS RETURNED TO 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 WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390612 ↗
• MalfunctionFeb 17, 2026Degraded

  A DEVICE WAS RETURNED TO 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 WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361661 ↗
• MalfunctionFeb 16, 2026Overheating of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION BIPAP AUTOSV DEVICE. THE PATIENT HAS ALLEGED BURN MARKS ON BOTTOM OF THE DEVICE. THERE WAS NO REPORT OF HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO PRODUCT INVESTIGATION LABORATORY (PIL) AND EVALUATED. DURING EVALUATION PIL CAN CONFIRM POTENTIAL BURN MARKS ON THE EXTERIOR OF THE BOTTOM ENCLOSURE EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349647 ↗
• MalfunctionJan 7, 2026Degraded

  THE DREAMSTATION BIPAP 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, IT WAS VISUALLY INSPECTED, AND THE ENGINEER FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION INSIDE THE BLOWER KIT AND DISPLAYED ERROR CODES: 22 (ERR_MOTOR_FLUX_MAGNITUDE,), ERROR CODE: 226 (ERR_SENSOR_PRESS_UNRELIABLE), ERROR CODE: 94 (ERR_RTC_STOPPED,). THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995145 ↗
• MalfunctionNov 27, 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. DURING THE EVALUATION, THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS 0 ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION THERE WAS VISIBLE FOAM DEGRADATION AND UNIT WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663470 ↗
• MalfunctionNov 26, 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 CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660308 ↗
• MalfunctionNov 20, 2025Degraded; Degraded

  A DREAMSTATION BIPAP AUTOSV 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 PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED AN ERROR CODE PRESENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612818 ↗
• DeathNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A DREAMSTATION BIPAP AUTOSV DEVICE HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARM REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 23581755 ↗
• MalfunctionOct 17, 2025Degraded; Degraded

  A DREAMSTATION BIPAP AUTOSV 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 AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS FOUND. ADDITIONALLY, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325594 ↗
• MalfunctionSep 9, 2025Degraded; Degraded

  A DREAMSTATION BIPAP AUTOSV DEVICE WAS RETURNED TO A MANUFACTURER 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 PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED AN ERROR CODES PRESENT IN THE DEVICE. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23010884 ↗
• MalfunctionAug 26, 2025Degraded; Degraded

  A DREAMSTATION BIPAP AUTOSV DEVICE WAS RETURNED TO THE MANUFACTURER 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 PARTICLES. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899941 ↗
• MalfunctionJun 16, 2025Degraded; 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. THERE WAS NO ALLEGATION REPORTED BY THE PATIENT. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. 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 22210837 ↗
• MalfunctionJun 15, 2025Degraded; 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 MOUTH WAS DRY AND DEVICE WILL NOT TURN ON/DEVICE NOT FUNCTIONING. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Dry Mouth

  MAUDE report 22208605 ↗
• MalfunctionJun 13, 2025Degraded; 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. THERE WAS NO ALLEGATION REPORTED BY THE PATIENT. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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 22201126 ↗
• MalfunctionJun 12, 2025Degraded; Degraded

  THE DREAMSTATION BIPAP AUTOSV DEVICE WAS RETURNED TO A 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 VISUALLY INSPECTED DURING THE EVALUATION, AND EVIDENCE OF FOAM PARTICLES/DEGRADATION WAS FOUND. THE DEVICE WAS SCRAPPED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194168 ↗
• MalfunctionJun 12, 2025Degraded; 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 WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER ALLEGING VISUALIZATION OF PARTICLES RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. NO MEDICAL INTERVENTION WAS SPECIFIED. 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 22193239 ↗
• MalfunctionJun 11, 2025Degraded; 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 THAT THE PATIENT ALLEGING DIFFICULTY IN SLEEP. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. 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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22183350 ↗
• MalfunctionJun 10, 2025Degraded; Degraded

  THE DEVICE WAS RETURNED TO 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 SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180582 ↗
• MalfunctionMay 30, 2025Degraded; 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. THERE WAS NO ALLEGATION REPORTED BY THE PATIENT. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. 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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113295 ↗
• MalfunctionMay 20, 2025Degraded; 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, DEVICE NOT FUNCTIONING AND OTHER THERMAL ISSUE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Dyspnea

  MAUDE report 22050611 ↗
• MalfunctionApr 22, 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/SCRAPPED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE VISIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879093 ↗
• MalfunctionMar 26, 2025Degraded; 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 PATIENT ALLEGES VISUALIZATION OF PARTICLES IN DEVICE. 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 21702510 ↗
• MalfunctionMar 18, 2025Degraded; 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 ALLEGES VISUALIZATION OF PARTICLES IN DEVICE. 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 21630937 ↗