BiPAP ST 00 (REF 1067P)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00606959039209), received between Jul 27, 2021 and May 29, 2025 — classified as 5 deaths, 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Degraded” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathMay 29, 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 THAT THE PATIENT DIED IN THE HOSPITAL. THERE WAS REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURE FOR 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 22109139 ↗
• InjuryMar 23, 2025Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION REGARDING A BIPAP S/T C-SERIES DEVICE. A HEALTHCARE FACILITY REPORTED THAT THE DEVICE WENT INTO AUTOMATIC POWER OFF ABOUT A HALF AN HOUR INTO USE. THERE IS AN ALLEGATION THAT THE PATIENT'S DYSPNEA WORSENED, EXPERIENCED CONFUSION AND DROWSINESS, AND THE PCO2 WAS READING HIGH. PULMONARY ENCEPHALOPATHY WAS CONSIDERED, AND THE NON-INVASIVE VENTILATOR WAS IMMEDIATELY SWITCHED. THE PATIENT'S CONSCIOUSNESS GRADUALLY RECOVERED, AND HE WAS CONSCIOUS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Blood Bicarbonate Increased; Confusion/ Disorientation; Dyspnea; Sleepiness/Drowsiness/Somnolence

  MAUDE report 21673407 ↗
• MalfunctionJan 3, 2025Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING NO POWER FOR A BIPAP S/T C SERIES DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM MAIN BOARD WAS REPLACED TO ADDRESS THE ISSUE. AFTER REPLACING THE PART ON THE DEVICE. THE DEVICE PASSED ALL TEST AND WAS DETERMINED TO BE OPERATIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074056 ↗
• MalfunctionApr 17, 2024Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WOULD NOT START. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126011 ↗
• DeathFeb 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION STATING A DEATH OCCURRED WHILE A BIPAP S/T C SERIES VENTILATOR WAS IN USE BY A PATIENT. THE FAMILY MEMBER REPORTED THAT ON (B)(6), THERE WAS NO ABNORMAL ALARM WHILE THE DEVICE WAS IN USE. THE POWER WAS CUT OFF BETWEEN 2:09AM TO 2:38AM ON (B)(6) AND THE SYSTEM WAS SHUT DOWN. THE FAMILY MEMBER STATES AFTER THE POWER WERE RESTORED, THE PATIENT WAS FOUND DEAD AT 5AM DUE TO THE PATIENT'S INABILITY TO MOVE TO TURN THE TREATMENT BUTTON BACK ON. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18660277 ↗
• DeathFeb 2, 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 "THE POSSIBILITY OF FOAM DEGRADING INTO PARTICLES, WHICH MAY ENTER THE AIR PASSAGE OF THE DEVICE AND BE INHALED BY THE USER". THE PATIENT "PASSED AWAY DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)" AFTER USING THE DEVICE. 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)

  MAUDE report 18636086 ↗
• MalfunctionOct 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT COULD NOT TOLERATE THE VENTILATOR AND STOPPED IT. THE PATIENT ALLEGES DIFFICULTY BREATHING AND DIZZINESS. 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: Dizziness; Dyspnea

  MAUDE report 18025062 ↗
• DeathApr 20, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT WAS IN THE HOSPITAL AND THE PATIENT'S BLOOD OXYGEN LEVEL DECREASED. THE DEVICE WAS CHANGED TO A DIFFERENT DEVICE. THE PATIENT EXPIRED AS A RESULT OF A CARDIAC ARREST. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: Cardiac Arrest

  MAUDE report 14160515 ↗
• InjuryMar 28, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), PULMONARY HEART DISEASE AND PULMONARY HYPERTENSION. THE PATIENT DID NOT REPORT TO RECEIVE MEDICAL INTERVENTION. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Pulmonary Hypertension; Unspecified Heart Problem

  MAUDE report 13932617 ↗
• InjuryOct 13, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP LUNG INFECTIONS. THE PATIENT WAS HOSPITALIZED IN RESPONSE TO THE REPORTED EVENT. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Respiratory Tract Infection

  MAUDE report 12623230 ↗
• DeathJul 27, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND RESULTED IN A PATIENT'S DEATH. NO FURTHER DETAILS REGARDING THE ALLEGATION ARE CURRENTLY KNOWN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cardiac Arrest

  MAUDE report 12235798 ↗
• InjuryJul 27, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP LUNG CANCER. THE DETAILS OF THE MEDICAL INTERVENTION THAT THE PATIENT REQUIRED ARE CURRENTLY UNKNOWN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Cancer

  MAUDE report 12234684 ↗

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 Respiron