Infant Flow SiPAP 677-002Recalls & reported problems
Carefusion Corporation · INFANT FLOW SIPAP TRANSDUCER INTERFACE GENERAL ASSEMBLY · Class 2
All models of Infant Flow SiPAP (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10846446005387), received between Feb 1, 2019 and Feb 21, 2021 — classified as 7 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (15 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 16, 2026.
Most reported problems
Device problems
- Mechanical Problem15
- Display or Visual Feedback Problem3
- Battery Problem1
- Gas/Air Leak1
- No Display/Image1
- Pressure Problem1
Patient problems
- No Information8
- No Consequences Or Impact To Patient5
- No Patient Involvement5
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2021No Display/Image; No Display/Image
VYAIRE MEDICAL RECEIVED A CUSTOMER REPORT OF A DEVICE WHERE THE SCREEN ON THE SIPAP IS WHITE AND IN ALARM. THE LED REMAINS RED. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11356627 ↗InjuryFeb 6, 2020Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THEIR INFANT FLOW SIPAP UNIT STOPPED WORKING DURING VENTILATION ON A PATIENT. THE AIR TANK WAS ON AND ITS PRESSURE WAS DOWN TO 300. THEY HAVE REPLACED THE TANK AND TRIED TO DO THE PRESSURE CALIBRATION AND IT WOULD NOT PASS. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9677761 ↗MalfunctionDec 12, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP DEVICE FLOW METER COULD NOT BE ADJUSTED PROPERLY AND POSITIVE END EXPIRATORY PRESSURE (PEEP) WOULD NOT BUILD UP SUFFICIENTLY. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Information
MAUDE report 9460285 ↗MalfunctionNov 25, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP TOUCH SCREEN WAS FREEZING UP. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Patient Involvement
MAUDE report 9371768 ↗MalfunctionOct 8, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP EXPERIENCED OXYGEN CONCENTRATION FLUCTUATIONS WHEN THE DEVICE IS TOUCHED. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Information
MAUDE report 9166825 ↗MalfunctionOct 8, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP EXPERIENCED FLOWMETER UNSTABLE MOVEMENT. THE FLOW FLUCTUATES BETWEEN 8 LITERS PER MIN TO 10 LITERS PER MIN. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Information
MAUDE report 9166821 ↗MalfunctionOct 8, 2019Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak
IT WAS REPORTED TO VYAIRE THAT THE SIPAP EXPERIENCED A GAS LEAK BETWEEN THE PROXIMAL CONNECTOR AND THE TUBE CONNECTOR. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Information
MAUDE report 9166820 ↗MalfunctionOct 1, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP DEVICE EXPERIENCED A WHITE SCREEN WHILE ATTEMPTING TO BOOT UP. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Patient Involvement
MAUDE report 9140718 ↗MalfunctionSep 19, 2019Battery Problem; Battery Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP UNIT EXPERIENCED BATTERY LEAKAGE. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Information
MAUDE report 9087030 ↗InjurySep 3, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SIPAP DEVICE EXPERIENCED LOSS OF PRESSURE WHILE CONNECTED TO A PATIENT. THE DEVICE ALSO ALARMED ERROR CODES 33 AND 42. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8957903 ↗InjuryAug 21, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP UNIT WOULD NOT PROVIDE THE SET OXYGEN PERCENTAGE WHILE CONNECTED TO A PATIENT. THE SIPAP STOPPED DELIVERING PRESSURE AND THE PATIENT WAS IMMEDIATELY REMOVED AND SWITCHED TO ANOTHER DEVICE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8918738 ↗MalfunctionJul 24, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP ALARMED ERROR CODE 59 AND WOULD NOT ALLOW MODE CHANGES. THE CUSTOMER ATTEMPTED TO CHANGE THE MODE TO BIPHASIC MODE AND WAS UNSUCCESSFUL. AT THIS TIME IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Information
MAUDE report 8823900 ↗InjuryJul 1, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP DEVICE WAS DELIVERING LOW PRESSURE WHILE CONNECTED TO A PATIENT. THE PATIENT WAS REMOVED FROM THE DEVICE AND SWITCHED TO ANOTHER THE UNIT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8749233 ↗MalfunctionJun 19, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP UNIT EXPERIENCED A BLANK SCREEN DURING START-UP. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE
Patient problems: No Patient Involvement
MAUDE report 8713579 ↗InjuryJun 12, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP UNIT ALARMED ERROR 33 WHILE CONNECTED TO A PATIENT. THE CUSTOMER STATED THAT ONCE THE DEVICE ALARMED ERROR CODE 33, THE SCREEN LOCKED AND DID NOT ALLOW FOR PROPER CHANGES. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON ANOTHER UNIT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8693016 ↗MalfunctionMay 16, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP UNIT WAS DELIVERING UNSTABLE FLOW. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Information
MAUDE report 8615426 ↗MalfunctionApr 19, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP FLOWMETER WAS JUMPING FROM 8 LITERS PER MINUTE TO 12 LITERS PER MINUTE AND IS VERY UNSTABLE. THE CUSTOMER DOES NOT KNOW IF THERE WAS ANY PATIENT INVOLVEMENT WITH THE REPORTED ISSUE.
Patient problems: No Information
MAUDE report 8532980 ↗MalfunctionApr 5, 2019Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE "INTERNAL PRESSURE DROP". THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8487637 ↗InjuryMar 20, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP UNIT STOPPED DELIVERING OXYGEN WHILE TRANSPORTING A PATIENT. THE PATIENT WAS IMMEDIATELY REMOVED FROM THE DEVICE AND PROVIDED POSITIVE PRESSURE VENTILATION VIA MANUAL RESUSCITATOR. THE CUSTOMER STATED THAT PATIENT HARM IS UNKNOWN AT THIS TIME. THE BABY SUFFERED FROM UNKNOWN ACIDOSIS AND TRIED TO COMPENSATE IT BY INCREASING RESPIRATION. THIS WAS THE REASON TO TRANSPORT THE BABY TO THE UNIVERSITY HOSPITAL. AT THIS POINT, THERE IS NO INDICATIONS ABOUT BRAIN DAMAGE.
Patient problems: Low Oxygen Saturation
MAUDE report 8436518 ↗MalfunctionFeb 5, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP FLOW METER BALL GETS STUCK CAUSING THE MEAN AIRWAY PRESSURE (MAP) TO GET STUCK. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Patient Involvement
MAUDE report 8306823 ↗InjuryFeb 1, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP UNIT SHUT DOWN WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8298941 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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