Phonix System One 60 Series PHONIX 3i A-Flex System One 60 Series H&LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00606959030732), received between Feb 10, 2022 and Jun 7, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Degraded” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Degraded; Degraded

  A PHÖNIX 3I A-FLEX 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. THERE WAS NO REPORT OF PATIENT INJURY OR HARM. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488555 ↗
• MalfunctionJun 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. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. A DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION 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 THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND HAS VISUALIZATION OF FOAM PARTICLES. IN ADDITION TO ABOVE FINDINGS, THERE WAS A PRESENT OF CONTAMINATION IN THE DEVICE, WHICH IS DUST/DIRT. THE DEVICE WAS ROUTED TO SCRAP. 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 19455608 ↗
• MalfunctionMay 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. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DURING EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, FOAM PARTICLES AND TOBACCO CONTAMINATION WAS FOUND IN THE DEVICE. POWER CONNECTOR WAS FOUND TO BE DESTROYED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312361 ↗
• MalfunctionJul 15, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO EXPERIENCING HEADACHES, DIZZINESS, PALPITATIONS AND SHORTNESS OF BREATH FOR ABOUT 10 YEARS. 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: Arrhythmia; Dizziness; Dyspnea; Headache

  MAUDE report 15031344 ↗
• MalfunctionFeb 10, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT TO HAVE KIDNEY CANCER. THE MEDICAL INTERVENTION THAT THE PATIENT RECEIVED IN RESPONSE TO THE EVENT IS CURRENTLY UNKNOWN. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Cancer; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509909 ↗