VELARecalls & reported problems across all models

We found 5 models of VELA by Carefusion Corporation in the FDA's device registry (GUDID). Together they are named in 2,569 adverse event reports in the FDA's MAUDE database, received between Oct 29, 2018 and Jun 17, 2024 — classified as 6 deaths, 450 injuries, 2,113 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (1,986 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 VELA problems

VELA models

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

• Vela 16600

  Ventilator, Continuous, Facility Use
  4 deaths1,225 reports
• VELA 16532-00

  Ventilator, Continuous, Facility Use
  2 deaths1,033 reports
• VELA 16531-00

  Ventilator, Continuous, Facility Use
  198 reports
• VELA 16530-00

  Ventilator, Continuous, Facility Use
  111 reports
• Vela 16532-01

  Ventilator, Continuous, Facility Use
  2 reports

Recent VELA adverse event reports

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

• MalfunctionJun 17, 2024Failure to Recalibrate; Failure to Recalibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A CIRCUIT DISCONNECT ALARM OCCURRED. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19551704 ↗
• MalfunctionJun 12, 2024Low Readings; Low Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING A PREVENTATIVE MAINTENANCE CHECK THE TECHNICIAN REPLACED THE BLENDER AND FOUND THAT THE FIO2 WAS NOT IN SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19524134 ↗
• MalfunctionJun 7, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR HAD A PROBLEM WITH THE EXHALATION FLOW TRANSDUCER FAULT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484887 ↗
• MalfunctionJun 6, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THEY RECEIVED PO FOR NEW MAIN BOARD DUE TO PERSISTENT XDCR FAULT PROCESSED ORDER. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480413 ↗
• MalfunctionJun 5, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A LOW O2 INLET ERROR WAS OBSERVED. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469265 ↗
• MalfunctionMay 20, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A XDCR FAULT AND AUTO-CYCLE OCCURRED WITH THE VELA VENTILATOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355466 ↗
• InjuryMay 16, 2024Low Readings; Low Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA REPORTED LOW VTE WHILE UNIT WAS ON PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19333247 ↗
• InjuryMay 13, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MAIN BOARD FOR DEVICE ALARMED TRANSDUCER FAULT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306106 ↗
• MalfunctionMay 6, 2024Gas Output Problem; Gas Output Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT AN O2 LEAK SOUNDED. NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255336 ↗
• MalfunctionMay 2, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO VYAIRE MEDICAL A HIGH PPEEK AT 40 TRIGGERS A CIRCUIT OCCLUSION ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231911 ↗
• MalfunctionMay 1, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VELA VENT HAD PERSISTENT XDCR FAULT CAUSING VENT NOT TO CYCLE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222500 ↗
• MalfunctionApr 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS AN AUDIBLE LEAK COMING FROM SAFETY VALVE ON THE BLENDER ASSEMBLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212086 ↗
• MalfunctionApr 29, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT AN O2 RANGE ERROR ALARM OCCURRED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202585 ↗
• MalfunctionApr 26, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT BIOMED CALLED REQUESTING ONSITE SERVICE FOR MOTOR FAULT ALARM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19193498 ↗
• MalfunctionApr 25, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PREVENTATIVE MAINTENANCE THE VELA VENT HAS XDCR MOTOR FAULT, LOW PIP AND LOW VTE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19186000 ↗

Other Carefusion Corporation products

• LTV 1200 VENTILATOR2 models · 362 reports
• AVEA11 models · 296 reports
• Infant Flow SiPAP7 models · 109 reports
• LTV8 models · 97 reports
• 3100A HFOV7 models · 82 reports
• 3100B HFOV2 models · 64 reports
• AirLife23 models · 41 reports
• Blender6 models · 33 reports