3100B HFOVRecalls & reported problems across all models

We found 2 models of 3100B HFOV by Carefusion Corporation in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2018 and Jun 18, 2024 — classified as 1 death, 9 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (40 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 3100B HFOV problems

3100B HFOV models

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

• 3100B HFOV 770155

  Ventilator, High Frequency
  1 death61 reports
• 3100B HFOV 770155-RFB

  Ventilator, High Frequency
  3 reports

Recent 3100B HFOV adverse event reports

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

• InjuryJun 18, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DEVICE WORKED FINE UNTIL THE 14-15TH HOUR WHEN THEY HEARD A LOUD HIGH-PITCHED WHISTLING SOUND AND THE PISTON STOPPED (A050402 GAS/AIR LEAK). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562654 ↗
• MalfunctionFeb 1, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B WHEN DEVICE IS POWERED ON, THE MAP INCREMENTALLY INCREASED TO MAX (~60CMH2O) WITHOUT ANY INTERVENTION. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622970 ↗
• MalfunctionJan 18, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED TO VYAIRE MEDICAL THAT TEH 3100B VENTILATOR MAP (MEAN AIRWAY PRESSURE) WONT ADJUST BELOW 4CMH2O DURING PRESSURE XDCR (TRANSDUCER) ADJUSTMENTS IN THE 2K. 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 18536879 ↗
• MalfunctionJan 2, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT UNSTABLE FREQUENCY OCCURRED ON THE 3100 B VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432523 ↗
• MalfunctionDec 19, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT NO MEAN AIRWAY PRESSURE AND DELTA P OCCURRED ON THE 3100 B VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361130 ↗
• MalfunctionAug 31, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE 3100B VENTILATOR PISTON POSITION WAS NOT DISPLAYING. THE AMPLITUDE, INSPIRATORY TIME (NORMALLY 33), AND FREQUENCY (NORMALLY 3-15) WERE ALL DISPLAYING ABNORMAL VALUES OF 52. 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 17666697 ↗
• MalfunctionJul 18, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL AN EXCESSIVE CONDENSATION IN ALL LINES OF THE 3100B VENTILATOR. IT WAS ALSO STATED THAT THE UNIT WAS FAILING TO HOLD A PRESS. THE ISSUE HAPPENED DURING PATIENT USE. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346937 ↗
• MalfunctionJun 29, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR HAD THE BATTERY LOW LED LIT. 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 17232809 ↗
• MalfunctionJun 19, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT ISSUES WITH PEAK TO PEAKS OCCURRED ON THE 3100 B VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153354 ↗
• MalfunctionApr 11, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR CAN ONLY GET 35CM ON THE MAP (MEAN AIRWAY PRESSURE). 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 16718705 ↗
• MalfunctionFeb 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT UNIT IS NOT PRESSURIZING ON THE 3100 B DEVICE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390111 ↗
• MalfunctionNov 22, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR MAP (MEAN AIRWAY PRESSURE) IS READING NEGATIVE NUMBERS AND FLUCTUATING BETWEEN -0.7 AND- 0.4, THERE IS NO CIRCUIT ON THE UNIT. THE DRIVER SEEMS TO BE PUSHED OUT, WITH NO AIR PLUGGED IN. 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 15849671 ↗
• MalfunctionOct 4, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE UNIT WILL NOT PRESSUURIZE ON THE 3100 B 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 15541048 ↗
• MalfunctionSep 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR MAP (MEAN AIRWAY PRESSURE) FLUCTUATES AT 10CMH2O. 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 15472965 ↗
• MalfunctionAug 26, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED TO VYAIRE MEDICAL DEVICE OVERHEATED AND STOPPED OSCILLATING DURING USE ON A PATIENT ON THE 3100 B 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 15307478 ↗

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