BiPAP A40 00 (REF 1109599)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00606959042773), received between Oct 25, 2024 and Nov 26, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2024Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR STOPPED OPERATING. 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 MAIN BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786168 ↗
• MalfunctionNov 26, 2024Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR STOPPED OPERATING. 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 MAIN BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784851 ↗
• MalfunctionNov 21, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS SHUT DOWN. 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 MAIN BOARD WAS 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 20746022 ↗
• MalfunctionNov 21, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS SHUT DOWN. 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 MAIN BOARD WAS 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 20745995 ↗
• MalfunctionNov 18, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED AND THE DEVICE FAILED TO ALARM. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS SENT TO A SERVICE CENTER FOR EVALUATION. THE VENTILATOR INOPERATIVE CONDITION WAS DUPLICATED. THE DEVICE'S MAIN BOARD WAS REPLACED TO PREVENT REOCCURRENCE. THE UNIT WAS CONFIRMED TO BE WORKING PROPERLY AFTER REPLACEMENT. 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 20712181 ↗
• MalfunctionOct 25, 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 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S MAIN BOARD WAS 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 20533222 ↗