Infant Flow SiPAP 675-CFG-005Recalls & reported problems
Carefusion Corporation · ASSY MK3 IF DRVR CONFIG US OVRLY/ PLUS/ EN · Class 2
All models of Infant Flow SiPAP (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Vyaire SiPAP ventilator, made by CareFusion, is a continuous-use facility ventilator. The 29 reports mostly describe the unit not building pressure or not delivering breaths, gas leaking out of the exhaust, internal leaks, and a damaged display. Three reports involved injuries; no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10846446004847), received between Jul 9, 2019 and Apr 8, 2024 — classified as 3 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (11 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem11
- Leak/Splash5
- Infusion or Flow Problem3
- Pressure Problem3
- No Pressure2
- Defective Alarm1
- Device Alarm System1
- Erratic or Intermittent Display1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Patient Involvement2
- No Information1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THE SIPAP IS IN BIPHASIC MODE, THE BREATHS WILL NOT DELIVER NO MATTER WHAT RATE IS SET. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059454 ↗MalfunctionApr 4, 2024No Pressure; No Pressure
IT WAS REPORTED TO VYAIRE MEDICAL THE VENT IS NOT PRESSURIZING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047222 ↗MalfunctionMar 4, 2024No Pressure; No Pressure
IT WAS REPORTED TO VYAIRE MEDICAL THE SIPAP WAS NOT PRESSURIZING AND THAT ALL OF THE GAS WAS COMING FROM THE EXHAUST. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18826493 ↗MalfunctionOct 3, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT SIPAP VENTILATOR HAD AN EXCESSIVE LEAK FROM THE EXHAUST. THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17865033 ↗MalfunctionJul 11, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THE SIPAP HAVE A DAMAGED DISPLAY. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17302825 ↗InjuryApr 28, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR SHUT DOWN ON PATIENT. IT WAS ALSO STATED THAT AN E50 AND AN E40 ALARM HAS OCCURRED ON THE UNIT. FURTHERMORE, THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16834971 ↗InjuryMar 27, 2023Leak/Splash; Leak/Splash
JIT WAS REPORTED TO VYAIRE MEDICAL THAT UNIT HAS AN INTERNAL LEAK DURING USE ON A PATIENT ON THE SIPAP VENTILATOR. THE CUSTOMER REPORTED THE UNIT WAS REPLACED. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16624812 ↗MalfunctionFeb 8, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT DEVICE IS CONSTANTLY LEAKING FROM IPX1 PORT ON THE BACK OF 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 16327235 ↗MalfunctionSep 14, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS A LARGE LEAK IN EXHALATION BLOCK ON THE SIPAP VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15420240 ↗MalfunctionJul 25, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR TOUCH SCREEN WAS NOT WORKING. AT THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15097160 ↗MalfunctionJun 8, 2022Pressure Problem; Pressure Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT A SIPAP VENTILATOR WAS OVER PRESSURIZING AND THEN POPPING OFF. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14640167 ↗MalfunctionMar 15, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED FLUCTUATING POSITIVE END EXPIRATORY PRESSURE ON THE SIPAP VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13766404 ↗MalfunctionMar 15, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED FLUCTUATING POSITIVE END EXPIRATORY PRESSURE DURING USE ON A PATIENT ON THE SIPAP VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13766306 ↗MalfunctionMar 15, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED FLUCTUATING POSITIVE END EXPIRATORY PRESSURE ON THE SIPAP VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13766190 ↗MalfunctionFeb 7, 2022Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THE SIPAP WAS SOUNDING LIKE IT HAD A LEAK. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13476750 ↗MalfunctionDec 24, 2021Pressure Problem; Pressure Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR WAS NOT BUILDING UP PRESSURE. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13083273 ↗MalfunctionDec 1, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE BLOCK ABOVE THE WATER TRAP IS INTERNALLY LEAKING OF THE SIPAP VENTILATOR. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12909883 ↗MalfunctionNov 16, 2021Pressure Problem; Pressure Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR UNIT JUST FINISHED PM, NOW AT FLOW OF 8 GENERATING PRESSURE GREATER THAN 10 CAUSING UNIT TO DUMP. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12823868 ↗MalfunctionNov 9, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED CANNOT GET THE DEVICE TO PRESSURIZE ABOVE 1.7CENTIMETERS 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 12782848 ↗MalfunctionNov 7, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE SIPAP VENTILATOR UNIT WAS HAVING FIO2/FRACTION OF INSPIRED OXYGEN FLUCTUATE. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12756143 ↗MalfunctionSep 16, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LCD (LIQUID CRYSTAL DISPLAY) IS DIM AND NOT RESPONDING. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12483294 ↗MalfunctionJul 20, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED HE WAS HAVING ISSUE WITH THE OXYGEN 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 12200129 ↗InjuryJul 15, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE SIPAP VENTILATOR EXPERIENCED WENT INTO DEMO MODE WHILE ON PATIENT. THE DISPLAY SHOWED UNIT WAS IN LIVE DEMO MODE BUT CONTINUED TO FUNCTION PROPERLY. AS AN INTERVENTION, THEY REMOVED UNIT FROM PATIENT. RE-SET UNIT INTO NORMAL MODE AND PUT THE PATIENT BACK. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12178141 ↗MalfunctionJul 15, 2021Improper Flow or Infusion; Improper Flow or Infusion
THE CUSTOMER REPORTED FIO2 (FRACTION OF INSPIRED OXYGEN) INACCURACY WITH THE LOW FLOW BLENDER. IT WAS STATED THAT THE DEVIATION IS TOO BIG. THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT WITH THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12174938 ↗MalfunctionApr 6, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED BLENDER FOR REPAIR FROM THE SIPAP VENTILATOR. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11624971 ↗
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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