Infant Flow SiPAP 27416-001 (UDI 10846446063486)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10846446063486), received between Apr 16, 2019 and Apr 4, 2024 — classified as 6 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (29 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024No Display/Image; No Display/Image

  IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE SIPAP VENTILATOR IN WHICH THE END USERS ARE REPORTING THAT WHEN THEY POWERED ON THE DEVICE, THE SCREEN 'WENT BLANK.'. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041507 ↗
• MalfunctionMar 21, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED TO VYAIRE MEDICAL THAT PRE-USE CHECK WAS BEING RAN, THEY WERE ABLE TO DO THE O2 CALIBRATION AND IT PASSED. AFTER THAT THE UNIT WAS "ALARMING" BUT NOT SURE WHY OR IF THERE WAS AN ERROR CODE ETC. FOUND THAT WE HAVE NO HISTORY OF A PM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949223 ↗
• MalfunctionJan 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT LEAK IN UNIT FROM EXHALATION PORT OCCURRED ON THE SIPAP VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584642 ↗
• MalfunctionNov 9, 2023Gas/Air Leak; Improper Flow or Infusion; Gas/Air Leak; Improper Flow or Infusion

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR HAS LOUD GAS FLOW CONSTANTLY FROM THE EXHAUST. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102567 ↗
• InjuryNov 6, 2023Mechanical Problem; No Pressure; Mechanical Problem; No Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THE INFANT FLOW SIPAP HAS NOT HOLDING PRESSURE DURING PATIENT USE. FURTHERMORE, THE PATIENT WAS SWAPPED IN A DIFFERENT VENTILATOR AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074685 ↗
• MalfunctionOct 20, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR IS NOT WORKING CORRECTLY AND MAKES NOISE. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976520 ↗
• MalfunctionAug 23, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR SCREEN IS STILL FLICKERING. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608769 ↗
• MalfunctionAug 3, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR HAS EXCESS LEAK WHEN HIGH PRESSURE GAS SOURCES ARE CONNECTED. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455428 ↗
• MalfunctionJul 26, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR HAS A LARGE BLEED COMING FROM THE BACK WHEN MEDICAL GASES ARE CONNECTED. AT THIS TIME, THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401692 ↗
• MalfunctionJul 21, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BLENDER OF THE INFANT SIPAP VENTILATOR BLEEDS EXCESSIVELY. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374906 ↗
• MalfunctionJul 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT LEAK INTERNALLY OCCURRED ON THE SIPAP VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17331032 ↗
• MalfunctionJun 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE INFANT FLOW SIPAP VENTILATOR ONLY DELIVERS 80% FIO2 (FRACTION OF INSPIRED OXYGEN). THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144813 ↗
• MalfunctionJun 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DISPLAY WAS NOT WORKING ON THE INFANT FLOW SIPAP VENTILATOR. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144804 ↗
• MalfunctionJun 7, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE INFANT SIPAP VENTILATOR HAS A FLICKERING DISPLAY. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079677 ↗
• MalfunctionApr 3, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BLENDER IS NOT WORKING ON THE SIPAP VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16670948 ↗
• MalfunctionMar 29, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR HAS ISSUE, X FLASHING UNDER NCPAP. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639777 ↗
• MalfunctionMar 8, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT FRACTION OF INSPIRED OXYGEN IS SET TO 100% BUT ON THE DISPLAY IT'S ONLY GOING TO 77% ON THE SIPAP VENTILATOR. E51 ERROR (OXYGEN SENSOR CANNOT BE CALIBRATED BY USER) ( BAD OFFSET OR HIGH GAIN) WAS ALSO PRESENT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504576 ↗
• MalfunctionDec 22, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP DEVICE WOULD NOT HOLD PRESSURE AND HAS AUDIBLE LEAK. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035701 ↗
• MalfunctionSep 24, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DISPLAY ON THE INFANT FLOW SIPAP WAS BLACK, AND THAT EVEN THOUGH THE UNIT WAS PLUGGED IN AC, IT RECEIVED A GREEN LIGHT INDICATING THAT IT WAS PLUGGED IN AC. HOWEVER, THE UNIT WILL NOT POWER ON. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481213 ↗
• MalfunctionAug 30, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VARE MEDICAL THAT THE SIPAP VENTILATOR IS ALARMING E33 (UNABLE TO AUTO ZERO PRESSURE SENSOR) AND HAS UNSTABLE PRESSURE. THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325358 ↗
• MalfunctionJun 17, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE SIPAP VENTILATOR'S POWER FAIL ALARM WAS NOT WORKING. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739580 ↗
• MalfunctionMay 9, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE SIPAP SCREEN DOES NOT DISPLAY. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342803 ↗
• MalfunctionApr 1, 2022Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED NOT PRESSURIZING ON THE SIPAP VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13980972 ↗
• MalfunctionMar 17, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE SIPAP SCREEN STOPPED WORKING WHILE ON PATIENT USE. THE UNIT STILL DELIVERING FLOW TO PATIENT BUT AUDIBLE ALARM WAS CONTINUOUSLY NOTED. THERE WAS NO PATIENT HARM REPORTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792182 ↗
• MalfunctionJan 19, 2022Pressure Problem; Pressure Problem

  THE CUSTOMER REPORTED PRESSURES TOO HIGH AND TRIPPING OVER PRESSURE ALARM ON THE SIPAP VENTILATOR, THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13294950 ↗