Infant Flow SiPAP 7772020LPRecalls & reported problems
Carefusion Corporation · PACKAGE ASSEMBLY,INFANT FLOW,LP · Class 2
All models of Infant Flow SiPAP (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 50846446004616), received between Jan 17, 2019 and Nov 3, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Defective Device” (1 report).
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
- Defective Device1
- Mechanical Problem1
- Pressure Problem1
Patient problems
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2020Defective Device; Defective Device
THE CUSTOMER REPORTED THAT THE 7772020LP PACKAGE ASSEMBLY, INFANT FLOW, LP HAS A VERY DIFFERENT ANGLE ON MEDIUM MASK THAN THE SMALL AND LARGE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. THE SAMPLE WAS REMOVED FROM THE PATIENT TO PREVENT PRESSURE INJURY AND NASAL OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10779191 ↗InjuryJan 15, 2020Pressure Problem; Pressure Problem
THE CUSTOMER REPORTED THAT THE INFANT FLOW WITH A SET OF CONTINUOUS POSITIVE NASAL PRESSURE GENERATOR HAD PRESSURE ANOMALY (POSITIVE EXPIRATORY PRESSURE AND INSPIRATORY PRESSURE) WHILE IN USE ON A PATIENT THAT RESULTED IN DECREASED OXYGEN SATURATION (SAO2) IN THE NEONATE. AT FIRST, THE OPERATOR CHANGED THE DEVICE WITH SAME LOT NUMBER (LOT: 0004076953), BUT NO SUCCESS. THEN THEY CHANGED THE DEVICE AGAIN WITH A DIFFERENT LOT NUMBER (LOT: 0004045851) AND NO RECURRENCE OF THE INCIDENT.
Patient problems: Low Oxygen Saturation
MAUDE report 9593438 ↗InjuryJan 17, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE THAT THE SIPAP FAILED WHILE CONNECTED TO A PATIENT. THE SUSPECT DEVICE ALARMED ERROR 33 AND WAS UNABLE TO AUTO ZERO. THE CLINICIAN IMMEDIATELY REMOVED THE PATIENT FROM THE 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 8258445 ↗
Other Ventilator, Continuous, Facility Use devices
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- 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 13, 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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