BiPAP A40 00 (REF 1109596)Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00606959042742), received between Oct 19, 2016 and Mar 19, 2026 — classified as 2 deaths, 1 injury, 78 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (39 reports).

1 FDA recall record name this device's identifier, 1 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. Aug 26, 2022Open, Classified

   Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

   Z-1655-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM THE PATIENT ALLEGING THEY CANNOT SLEEP AS THE BIPAP A40, FLOW GEN, INTERNATIONAL DEVICE IS ALARMING. THE PATIENT STATED THAT THEY HAD TWO (2) LUMPS TAKEN OUT ON THEIR LEFT LUNG AS THEIR LUNG COLLAPSED. A PHILIPS CLINICAL EXPERT ASSESSED THIS AS A SERIOUS INJURY AND THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE SERIOUS INJURY. THE CLINICAL EXPERT STATED THE ALLEGATION OF THE PATIENT STATING THE REMOVAL OF TWO LUMPS ON THE LEFT LUNG AND LUNG COLLAPSED ARE ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THE MENTIONED HARM UNABLE TO SLEEP DUE TO DEVICE ALARMING IS ASSESSED AS A NON-SERIOUS INJURY. LISTED AS THE REASON FOR USING THE DEVICE IS SLEEP APNEA. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AS PART OF THE COMPLAINT HANDLING PROCESS, THE MANUFACTURER WILL ATTEMPT TO RETRIEVE THE DEVICE FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONA

  Patient problems: Nodule; Unspecified Respiratory Problem

  MAUDE report 24643078 ↗
• MalfunctionFeb 9, 2026Circuit Failure; Degraded; Electrical /Electronic Property Problem

  AN A40 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 AND ERROR CODE E047 (VENTILATOR INOPERATIVE). DUE TO THE VENTILATOR INOPERATIVE ERROR, THE MAIN PCA BOARD WAS REPLACED. ADDITIONALLY, EXTREME DIRT AND MOISTURE CONTAMINATION WERE FOUND INSIDE THE DEVICE, AND THE DEVICE DATA IDENTIFIED AN ADDITIONAL UNRELATED ERROR CODE. THIS ERROR CODE WAS CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND IS NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THIS ERROR CODE CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS RETURNED REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298799 ↗
• MalfunctionFeb 9, 2026Degraded

  AN A40 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. NO ADDITIONAL FINDINGS. THE DEVICE WAS RETURNED REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294214 ↗
• MalfunctionFeb 9, 2026Degraded

  A A40 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. ADDITIONALLY, EXTREME DIRT AND MOISTURE CONTAMINATION WERE FOUND INSIDE THE DEVICE, THE MAIN PCA WAS REPLACED, AND 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 RETURNED REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293728 ↗
• MalfunctionFeb 9, 2026Circuit Failure; Degraded; Electrical /Electronic Property Problem

  AN A40 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 AND ERROR CODE E050 (VENTILATOR INOPERATIVE). DUE TO THE VENTILATOR INOPERATIVE ERROR, THE MAIN PCA BOARD WAS REPLACED. ADDITIONALLY, EXTREME DIRT AND MOISTURE CONTAMINATION WERE FOUND INSIDE THE DEVICE, AND THE DEVICE DATA IDENTIFIED ADDITIONAL 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 RETURNED REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293546 ↗
• MalfunctionFeb 9, 2026Degraded

  AN A40 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. NO ADDITIONAL FINDINGS. THE DEVICE WAS RETURNED REPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293542 ↗
• MalfunctionFeb 6, 2026Degraded

  A 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. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THIS IS 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 MALFUNCTION OF THE DEVICE WAS NOTED. THERE WERE NO ACTIONABLE ERRORS OBSERVED. THE DEVICE WAS REMEDIATED AND RETURNED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279923 ↗
• MalfunctionFeb 5, 2026Electrical /Electronic Property Problem

  A BIPAP A40 VENTILATOR WAS RETURNED TO A SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT A SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION HOWEVER, A VENTILATOR INOPERATIVE ERROR CODE INDICATING (DEFECTIVE EEPROM) WAS CONFIRMED IN THE EVENT LOG. NO REPAIR WAS PERFORMED. THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266273 ↗
• MalfunctionAug 11, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING ERROR CODES OCCURRED WHILE THE BIPAP A40 PRO DEVICE WAS IN PATIENT USE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A VENTILATOR INOPERATIVE ALARM CONDITION WAS OBSERVED. THIS ISSUE FALLS UNDER THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO A VENTILATOR INOPERATIVE CONDITION OCCURRING IN CERTAIN BIPAP, AND MECHANICAL VENTILATOR DEVICES. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039. THE DEVICE'S MAIN BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS FOUND TO BE CONTAMINATED WITH DIRT. NO PARTICLES WERE NOTED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776225 ↗
• MalfunctionMar 26, 2025Degraded; Degraded

  A BIPAP A40 DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICING RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, VISIBLE FOAM PARTICLES WERE FOUND, AND THE FOAM INSULATION WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, HIGH RATE, LOW MINUTE VENTILATION, LOW CIRCUIT LEAK, AND PATIENT DISCONNECT ERROR CODES WERE FOUND IN THE DEVICE'S ERROR LOG. IT IS ALSO NOTED THAT EXTREME DIRT AND MOISTURE WERE FOUND DURING THE EVALUATION. THE DEVICE SOFTWARE WAS UPGRADED, AND THE DEVICE PASSED ALL FINAL TESTING. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700699 ↗
• MalfunctionMar 26, 2025Degraded; Electrical /Electronic Property Problem; Degraded; Electrical /Electronic Property Problem

  A BIPAP A40 DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICING RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, VISIBLE FOAM PARTICLES WERE FOUND, AND THE FOAM INSULATION WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, A VENTILATOR INOPERATIVE ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG RELATING TO A PRESSURE FAIL. THERE IS NO DOCUMENTATION STATED ON WHAT WAS REPLACED TO RESOLVE THIS ISSUE. ADDITIONALLY, PT LOW PRESS AND POWER REDUCTION AC DISCONNECTED ERROR CODES WERE ALSO FOUND IN THE DEVICES ERROR LOG. IT IS ALSO NOTED THAT EXTREME DIRT AND MOISTURE WERE FOUND DURING THE EVALUATION. THE DEVICE SOFTWARE WAS UPGRADED, AND THE DEVICE PASSED ALL FINAL TESTING. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700692 ↗
• MalfunctionMar 26, 2025Degraded; Electrical /Electronic Property Problem; Degraded; Electrical /Electronic Property Problem

  A BIPAP A40 DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICING RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, VISIBLE FOAM PARTICLES WERE FOUND, AND THE FOAM INSULATION WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, TWO VENTILATOR INOPERATIVE ERROR CODES WERE FOUND IN THE DEVICE'S ERROR LOG RELATING TO A FLOW SENSOR COMMUNICATION AS WELL AS A PRESSURE SENSOR COMMUNICATION ERROR. THE MAIN PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUES. ADDITIONALLY, A LOW CIRCUIT LEAK ERROR CODE FOUND IN THE DEVICES ERROR LOG. IT IS ALSO NOTED THAT EXTREME DIRT AND MOISTURE WERE FOUND DURING THE EVALUATION. THE DEVICE SOFTWARE WAS UPGRADED, AND THE DEVICE PASSED ALL FINAL TESTING. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700143 ↗
• MalfunctionMar 26, 2025Degraded; Degraded

  A BIPAP A40 DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICING RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, VISIBLE FOAM PARTICLES WERE FOUND, AND THE FOAM INSULATION WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, A LOW CIRCUIT LEAK ALARM, POWER REDUCTION AC DISCONNECTED, SERIAL FLASH FILE ACCESS, AND A SERIAL FLASH COPY ERROR CODES WERE FOUND IN THE DEVICE'S ERROR LOG. IT IS ALSO NOTED THAT EXTREME DIRT AND MOISTURE WERE FOUND DURING THE EVALUATION. THE DEVICE SOFTWARE WAS UPGRADED, AND THE DEVICE PASSED ALL FINAL TESTING. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700140 ↗
• MalfunctionMar 26, 2025Degraded; Electrical /Electronic Property Problem; Degraded; Electrical /Electronic Property Problem

  A BIPAP A40 DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICING RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, VISIBLE FOAM PARTICLES WERE FOUND, AND THE FOAM INSULATION WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, A VENTILATOR INOPERATIVE ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG RELATING TO HIGH AC INPUT VOLTAGE. THE MAIN PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, A LOWER PRIORITY SOFT POWER LOSS ERROR CODE WAS FOUND IN THE DEVICES ERROR LOG. IT IS ALSO NOTED THAT EXTREME DIRT AND MOISTURE WERE FOUND DURING THE EVALUATION. THE DEVICE SOFTWARE WAS UPGRADED, AND THE DEVICE PASSED ALL FINAL TESTING. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700138 ↗
• MalfunctionMar 3, 2025Circuit Failure; Circuit Failure

  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 AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE BOARD WAS REPLACED. 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 21504121 ↗
• MalfunctionMar 3, 2025Circuit Failure; Circuit Failure

  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 BOARD WAS REPLACED. 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 21504120 ↗
• MalfunctionFeb 26, 2025Circuit Failure; Circuit Failure

  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 AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S BOARD WAS REPLACED. 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 21467517 ↗
• MalfunctionFeb 19, 2025Circuit Failure; Circuit Failure

  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'S BOARD WAS REPLACED. 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 21411705 ↗
• MalfunctionFeb 19, 2025Circuit Failure; Circuit Failure

  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'S BOARD WAS REPLACED. 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 21411704 ↗
• MalfunctionFeb 19, 2025Circuit Failure; Circuit Failure

  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'S BOARD WAS REPLACED. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN (B)(4), 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 (B)(4) WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411700 ↗
• MalfunctionFeb 19, 2025Circuit Failure; Circuit Failure

  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'S BOARD WAS REPLACED. 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 21411546 ↗
• MalfunctionFeb 18, 2025Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CONDITION WAS IDENTIFIED. THE DEVICE'S BOARD AND PRESSURE TUBBING WERE REPLACED TO ADDRESS THE ISSUE. 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 21395750 ↗
• MalfunctionFeb 5, 2025Circuit Failure; Circuit Failure

  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 AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S BOARD WAS REPLACED SINCE BOARD WAS DEFECTIVE. 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 21311947 ↗
• MalfunctionFeb 5, 2025Circuit Failure; Circuit Failure

  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 AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S BOARD WAS REPLACED. 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 21311944 ↗
• MalfunctionFeb 4, 2025Circuit Failure; Circuit Failure

  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 AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S THERAPY BOARD WAS REPLACED TO ADDRESS THE ISSUE. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN (B)(4), 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 (B)(4) WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307429 ↗