Infant Flow SiPAPRecalls & reported problems across all models

We found 7 models of Infant Flow SiPAP by Carefusion Corporation in the FDA's device registry (GUDID). Together they are named in 109 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2018 and Apr 8, 2024 — classified as 20 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (57 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Infant Flow SiPAP problems

Infant Flow SiPAP models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Infant Flow SiPAP 27416-001

  Ventilator, Continuous, Facility Use
  53 reports
• Infant Flow SiPAP 675-CFG-005

  Ventilator, Continuous, Facility Use
  29 reports
• Infant Flow SiPAP 677-002

  Ventilator, Continuous, Facility Use
  21 reports
• Infant Flow SiPAP 7772020LP

  Ventilator, Continuous, Facility Use
  3 reports
• Infant Flow SiPAP 27415-001

  Ventilator, Continuous, Facility Use
  1 report
• Infant Flow SiPAP 777040XS

  Ventilator, Continuous, Facility Use
  1 report
• Infant Flow SiPAP 777000S

  Ventilator, Continuous, Facility Use
  1 report

Recent Infant Flow SiPAP adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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