BiPAP A40 INX3100S19Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00606959055025), received between Dec 15, 2023 and Mar 25, 2026 — classified as 1 death, 23 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (11 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. May 9, 2025Open, Classified

   This device does not indicate for use in patients with respiratory failure.

   Z-2037-2025 · Root cause: Device Design · FDA record ↗

2. Mar 26, 2024Open, Classified

   Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

   Z-1813-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A BIPAP A40 PRO HAS AN ACTIVE VENTILATOR INOPERATIVE ALARM. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS REQUESTED FOR RETURN; HOWEVER, THE DEVICE EVALUATION HAS NOT BEEN COMPLETED AT THIS TIME. IF NEW INFORMATION BECOMES AVAILABLE THAT CHANGES THE ASSOCIATED MEDICAL DEVICE REPORTING, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687699 ↗
• MalfunctionMar 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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND NO ACTIONABLE ERRORS WERE OBSERVED. DURING VISUAL INSPECTION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED INSIDE THE DEVICE. NO REPAIRS WERE PERFORMED. THE DEVICE IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546692 ↗
• MalfunctionMar 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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND NO ACTIONABLE ERRORS WERE OBSERVED. DURING VISUAL INSPECTION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED INSIDE THE DEVICE. NO REPAIRS WERE PERFORMED. THE DEVICE IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546683 ↗
• MalfunctionMar 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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND NO ACTIONABLE ERRORS WERE OBSERVED. DURING VISUAL INSPECTION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED INSIDE THE DEVICE. NO REPAIRS WERE PERFORMED. THE DEVICE IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546681 ↗
• MalfunctionMar 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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND NO ACTIONABLE ERRORS WERE OBSERVED. DURING VISUAL INSPECTION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED INSIDE THE DEVICE. NO REPAIRS WERE PERFORMED. THE DEVICE IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546680 ↗
• MalfunctionMar 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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND NO ACTIONABLE ERRORS WERE OBSERVED. DURING VISUAL INSPECTION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED INSIDE THE DEVICE. NO REPAIRS WERE PERFORMED. THE DEVICE IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546678 ↗
• MalfunctionMar 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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND NO ACTIONABLE ERRORS WERE OBSERVED. DURING VISUAL INSPECTION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED INSIDE THE DEVICE. NO REPAIRS WERE PERFORMED. THE DEVICE IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546677 ↗
• MalfunctionMar 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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND NO ACTIONABLE ERRORS WERE OBSERVED. DURING VISUAL INSPECTION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED INSIDE THE DEVICE. NO REPAIRS WERE PERFORMED. THE DEVICE IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546676 ↗
• MalfunctionMar 2, 2026Degraded

  A BIPAP A40 PRO DEVICE WAS RETURNED TO THE 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. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484504 ↗
• MalfunctionJan 30, 2026Degraded

  A BIPAP A40 PRO DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND FOAM PARTICLES WERE OBSERVED. THE FOAM INSULATION NEEDS TO BE REPLACED TO RESOLVE THE ISSUE. NO REPAIRS WERE PERFORMED. THE DEVICE HAS BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222877 ↗
• MalfunctionJan 30, 2026Degraded

  THE BIPAP A40 PRO VENTILATOR WAS RETURNED TO THE 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. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR INVESTIGATION. DURING EVALUATION, EVIDENCE OF (FOAM DEGRADATION INSIDE THE ASSEMBLY, DETERIORATED FOAM) WAS PRESENT. THERE WERE NO REPAIRS AND THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222102 ↗
• MalfunctionOct 17, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE PRODUCT INVESTIGATION LABORATORY (PIL) FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING EVALUATION PIL COULD VERIFY THAT THE LOG TAKEN FROM THE UNIT, CONTAINS (11) ERR_VENT_INOP ALARMS AFTER (11)E-00050 ERR_PRESSURE_FAILED. ENGINEERING EVALUATION HAS FOUND THE CAUSE TO BE A CLOGGED ETCHED DISK. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328466 ↗
• MalfunctionMar 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CUSTOMER IS GETTING A VENTILATOR INOPERATIVE ALARM ON THE BIPAP A40 PRO DEVICE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039 DUE TO INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THERE WAS NO PATIENT HARM OR INJURY REPORTED WITH THIS NOTIFICATION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663719 ↗
• MalfunctionMar 21, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) FOR EVALUATION AND WAS ABLE TO CONFIRM ETCHED DISK IS PARTIALLY CLOGGED WITH DEBRIS. DURING THE EVALUATION, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE CUSTOMER HAS RECEIVED A REPLACEMENT. THE UNIT HAS BEEN SCRAPPED. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661289 ↗
• MalfunctionFeb 13, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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 21375873 ↗
• MalfunctionFeb 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO DEVICE WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY ALLEGED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039. THE BIPAP A40 PRO (INX3100S19) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 (1111169) AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: K121623.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304025 ↗
• MalfunctionNov 28, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR TURNS ON AND OFF. 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. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805692 ↗
• MalfunctionOct 9, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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. THIS MALFUNCTION IS PART OF A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH FSN-2023-CC-SRC-039. UPON REVIEW, THIS MALFUNCTION HAS BEEN DEEMED A REPORTABLE MALFUNCTION. THIS MALFUNCTION IF IT WERE TO RECUR COULD RESULT IN PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407053 ↗
• MalfunctionAug 15, 2024Electrical /Electronic Property Problem; Decrease in Pressure; Environmental Compatibility Problem; No Flow; Output Problem; Electrical /Electronic Property Problem; Decrease in Pressure; Environmental Compatibility Problem; No Flow; Output Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO RED ALARM CONDITION OCCURRED. THE REPORTER STATES THE DEVICE DASHBOARD TURNED RED AND STOPPED PROVIDING AIR TO THE PATIENT. THE FAMILY MEMBER RESTARTED THE DEVICE. THE PATIENT HAD DROWNING FOR A FEW MINUTES. 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 19991759 ↗
• DeathFeb 22, 2024Computer Software Problem; Computer Software Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED AND THE PATIENT DYING WHILE ON THE DEVICE. A LAB INVESTIGATION WAS PERFORMED AND STATED, "PIL VISUALLY INSPECTED THE BI-PAP A40 PRO AND DID NOT OBSERVE ANY VISUAL DEFECTS. IN ADDITION, THE TECH VERIFIED THAT THE UNIT WAS OPERATING ON SW VERSION 1.1.2.0 AT THE TIME OF THE EVENT. DURING THE PIL REVIEW OF THE LOG THE PIL VERIFIED MULTIPLE E96'S HAD OCCURRED WITH AN INCORRECT DATE OF (B)(6) 1970, OCCURRING BEFORE AN SD CARD INSERT ON (B)(6) 2022. THE PIL COULD ALSO CONFIRM A VENTILATOR INOPERATIVE SHOWING A DATE OF (B)(6) 2022 02:11 AM IN THE ALARM LOG OF THE DISPLAY IN THE UNIT ALARM LOG. HOWEVER, THE VENT INOP DOES NOT SHOW IN THE LOG. TECH VERIFIED THAT THE UNIT OPERATES AT THE PIL WITHOUT ISSUE OR ERROR CODE DURING UNIT OPERATION AT THE PIL. DUE TO THE UNIT MULTIPLE E96'S NOTED IN THE LOG AND THE VENT INOP NOTED IN THE ALARM LOG OF THE UNIT, THE PIL TECH REACHED OUT TO ENGINEERING. ENGINEERING HAS ADDED A INTERLEAVED LOG TO SHOW THE LOG ENTRIES THAT ARE CORRUPT. PER ENGINEERING , THIS IS A SOFTWARE ISSUE, FALLING UNDER EXISTING INVESTIGATIONS. EXTENSIVE INVESTIGATIONS HAVE TURNED UP EVIDENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18764583 ↗
• MalfunctionJan 17, 2024Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED, AND THE FILTER WAS DIRTY. THE FILTER WAS REPLACED WHICH RESULTED IN THE VENT INOPERATIVE CLEARING AFTER OBSERVATION. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531507 ↗
• MalfunctionDec 19, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE IS NOT YET EVALUATED. 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 18360345 ↗
• MalfunctionDec 15, 2023Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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 18337495 ↗
• MalfunctionDec 15, 2023Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SOMETIMES TURNS OFF AND START AGAIN. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336008 ↗