3100A HFOVRecalls & reported problems across all models

We found 7 models of 3100A HFOV by Carefusion Corporation in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2015 and Oct 27, 2023 — classified as 15 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (56 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 3100A HFOV problems

3100A HFOV models

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

• 3100A HFOV 768901-RNT

  Ventilator, High Frequency
  55 reports
• 3100A HFOV 768901-RFB

  Ventilator, High Frequency
  18 reports
• 3100A HFOV 11518-850S

  Ventilator, High Frequency
  3 reports
• 3100A HFOV 773997

  Ventilator, High Frequency
  2 reports
• 3100A HFOV 773996

  Ventilator, High Frequency
  2 reports
• 3100A HFOV 11518-850L

  Ventilator, High Frequency
  1 report
• 3100A HFOV 771374

  Ventilator, High Frequency
  1 report

Recent 3100A HFOV adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR HAS PRESSURE FLUCTUATIONS. 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 18017512 ↗
• MalfunctionOct 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE START/STOP BUTTON IS DAMAGED ON THE 3100 A VENTILATOR. CUSTOMER IS REQUESTING A DDI (DYNAMIC DISPLACEMENT INDICATOR) BOARD. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004172 ↗
• MalfunctionOct 12, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO THE (B)(6) MEDICAL THAT THE 3100 A VENT KEEPS STOPPING AND THE HERTZ WAS FLUCTUATING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928274 ↗
• MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR 'STOPPED WHILE ON A PATIENT'. THERE WAS NO PATIENT HARM REPORTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814585 ↗
• MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR 'STOPPED WHILE ON A PATIENT'. THERE WAS NO PATIENT HARM REPORTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814581 ↗
• MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR 'STOPPED WHILE ON A PATIENT'. THERE WAS NO PATIENT HARM REPORTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814561 ↗
• MalfunctionSep 12, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VYAIRE MEDICAL THAT UNIT SHUT DOWN WHILE ON A PATIENT ON THE 3100 A DEVICE. 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 17733676 ↗
• InjuryJul 19, 2022Product Quality Problem; Product Quality Problem

  THE CUSTOMER REPORTED THAT THE PATIENT'S CO2 WENT UP TO 12 AND THEN 20 EVEN THOUGH THE OSCILLATOR WAS ABLE TO OXYGENATE THE PATIENT, AND THIS COULD NOT BE CLEARED ON LOWER FREQUENCY OR INCREASED AMPLITUDE. ALSO, THERE WERE SEVERE "RAINOUTS" OR COPIOUS AMOUNTS OF WATER IN WATER TRAP, TUBING AND FILTERS. THE MAP WAS FLUCTUATING, CAUSING PATIENT TO DESATURATE. END USERS IMMEDIATELY ATTENDED TO THE PATIENT AND MADE THE SITUATION SAFE BY CLEARING CONDENSATION FROM THE SYSTEM (WATER TRAP REQUIRED EMPTYING TWICE IN 4 HOURS), CHANGING TO A DIFFERENT OSCILLATOR WITHOUT A FILTER, OR PUTTING THE PATIENT BACK ONTO CONVENTIONAL VENTILATION. THE ISSUE HAVE OCCURRED MULTIPLE TIMES ((B)(4)) ON DIFFERENT OSCILLATORS. HOWEVER, CURRENT OPINION OF THE END USERS IS THAT IT COULD BE RELATED TO THE BOXED PATIENT CIRCUIT ASSY, 31A, FILTERED, 850S AS NO NOTICEABLE PROBLEM WITH OLD PATIENT SETS (NO FILTER). CO2 - CARBON DIOXIDE. MAP - MEAN AIRWAY PRESSURE.

  Patient problems: Hypoventilation; Low Oxygen Saturation

  MAUDE report 15059691 ↗
• MalfunctionJul 19, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR WAS EXPERIENCING FREQUENCY ISSUES. THE UNIT IS SHUTTING DOWN WHEN TRYING TO RAISE THE FREQUENCY. THE ISSUE OCCURRED DURING PATIENT-USE. AT THIS TIME, THERE WAS NO INFORMATION FOR PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058355 ↗
• MalfunctionJun 29, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR'S MEAN AIRWAY PRESSURE (MAP) IS FLUCTUATING REALLY BAD DURING USE. THERE WAS NO KNOWN CONSEQUENCES OR IMPACT TO PATIENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14863615 ↗
• MalfunctionJun 24, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MEAN AIRWAY PRESSURE (MAP) OF 3100A VENTILATOR IS FLUCTUATING WHILE ON PATIENT USE. AT THIS TIME, THERE WAS NO INFORMATION REGARDING PATIENT HARM AND INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14810390 ↗
• MalfunctionJun 24, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR IS NOT HOLDING PRESSURE. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14810126 ↗
• MalfunctionJun 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR HAD FLUCTUATING MEAN AIRWAY PRESSURE (MAP) WHILE ON PATIENT. THERE WAS NO KNOWN CONSEQUENCES OR IMPACT TO PATIENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14794904 ↗
• MalfunctionJun 23, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED MINIMUM AIRWAY PRESSURE (PAW) ALARM IS STUCK ON REGARDLESS OF SETTINGS ON THE 3100 A 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 14794743 ↗
• MalfunctionJun 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR'S MAP IS OFF BY 30CMH2O. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14794729 ↗

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