BiPAP System One 60 Series BiPAP Auto BiFlex, w/HT Humid System One 60 Series, USRecalls & reported problems

Summary

The FDA's MAUDE database contains 548 adverse event reports that list this exact device (DI 00606959006027), received between Oct 7, 2021 and Sep 30, 2026 — classified as 6 deaths, 98 injuries, 444 malfunctions.

The most frequently reported specific device problem is “Degraded” (537 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 548 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954744 ↗
• MalfunctionJul 17, 2026Thermal Decomposition of Device

  A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A 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 SERVICE CENTER, THE UNIT WAS VISUALLY INSPECTED, AND A BURNT CONNECTOR WAS IDENTIFIED. BASED ON THE EVALUATION FINDINGS, THE DEVICE WAS FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25861006 ↗
• MalfunctionJun 26, 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 AUTO BIFLEX 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 FOUND EVIDENCE OF VISIBLE FOAM PARTICLES. 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 WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25642678 ↗
• MalfunctionJun 26, 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 AUTO BIFLEX 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 PARTICLES WAS FOUND. 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 WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641760 ↗
• MalfunctionJun 9, 2026Excessive Heating

  THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, THE THIRD-PARTY SERVICE CENTER FOUND A BURNT POWER CONNECTOR. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING AND INVESTIGATION. A FINAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25451927 ↗
• MalfunctionJun 9, 2026Circuit Failure; Contamination; Loose or Intermittent Connection

  THE BIPAP AUTO BIFLEX WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE EXHIBITED WATER DAMAGE AND HAS BURNT CONNECTOR. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. ADDITIONALLY, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444128 ↗
• MalfunctionJun 5, 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 AUTO BIFLEX 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 VISIBLE FOAM PARTICLES WAS FOUND. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DIRT 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 25415239 ↗
• MalfunctionJun 5, 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 AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH INITIAL ALLEGED COMPLAINT OF NO POWER. 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. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25412721 ↗
• MalfunctionMay 29, 2026Degraded

  A BIPAP AUTO BI-FLEX 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, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND OBSERVED VISIBLE FOAM PARTICLES WERE FOUND. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, ERROR CODES WERE PRESENT DURING EVALUATION. THE DEVICE WAS SCRAPPED AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25339444 ↗
• MalfunctionApr 9, 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 AUTO BIFLEX 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 WAS FOUND INSIDE THE BLOWER KIT. MOREOVER, THE DEVICE HAD 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. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835220 ↗
• MalfunctionMar 11, 2026Degraded

  A BIPAP AUTO BIFLEX 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 VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT AND OBJECT CODE INDICATES THE BLOWER CONTRIBUTED TO THE FOAM DEGRADATION. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED DUST CONTAMINATION. 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 24568538 ↗
• MalfunctionMar 10, 2026Degraded

  A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. 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. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST FAIL 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 24563266 ↗
• MalfunctionMar 10, 2026Degraded

  A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO THE 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. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN FOUND 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. FURTHERMORE, THE UNIT WAS SCRAPPED UPON COMPLETION OF THE DEVICE EVALUATION. 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 24562808 ↗
• MalfunctionMar 10, 2026Degraded

  A BIPAP AUTO BIFLEX+ 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, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM PARTICLES WERE FOUND. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION, AND A DESTROYED POWER CONNECTOR. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561664 ↗
• MalfunctionMar 10, 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 AUTO BIFLEX 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 WAS FOUND INSIDE THE BLOWER KIT. MOREOVER, THE DEVICE HAD 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. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560317 ↗
• MalfunctionMar 10, 2026Overheating of Device

  A BIPAP AUTO BIFLEX 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 BURNT POWER CONNECTOR WAS OBSERVED. ADDITIONALLY, DUST CONTAMINATION WAS PRESENT AND THE DEVICE WAS CORRECTED. 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 24557610 ↗
• MalfunctionMar 7, 2026Degraded

  A BIPAP AUTO BIFLEX 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, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND NO EVIDENCE OF FOAM PARTICLES IN THE ASSEMBLY YET, BLOWER FOAM DEGRADATION WAS NOTED. 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 24539730 ↗
• MalfunctionMar 6, 2026Contamination; 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. A BIPAP AUTO BIFLEX 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 BLOWER FOAM DEGRADATION WAS FOUND. 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 24539027 ↗
• MalfunctionMar 6, 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 AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING EVALUATION, NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS FOUND. MOREOVER, THE DEVICE HAD 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. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537254 ↗
• MalfunctionMar 6, 2026Degraded

  A BIPAP AUTO BIFLEX 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 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 24536248 ↗
• MalfunctionMar 6, 2026Degraded

  A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED 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 24531706 ↗
• MalfunctionMar 6, 2026Degraded

  A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED FLUID 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 24531694 ↗
• MalfunctionMar 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 AUTO BIFLEX 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 NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. THE DEVICES SOUND ABATEMENT FOAM WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE SERVICE TECHNICIAN FOUND 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 REPAIRED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506206 ↗
• MalfunctionFeb 26, 2026Degraded

  A BIPAP AUTO BIFLEX 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, THE THIRD PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT AND NOTED A BLOWER FOAM DEGRADATION. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED DUST CONTAMINATION, AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THERE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITION THAT ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENT. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BU THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND OR PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464197 ↗
• MalfunctionFeb 26, 2026Degraded

  A BIPAP AUTO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT AND BLOWER FOAM DEGRADATION. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED 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 24458727 ↗