VELA 16531-00 (UDI 10190752153363)Recalls & reported problems
Vyaire Medical, Inc. · VELA CF PLUS,DISS,GRN O2,TYPE K,ENG OVERLAY · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752153363), received between May 9, 2024 and Jun 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Calibrate” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Calibrate1
- No Device Output1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR SHOWS ¿LOW VE, LOW PIP, XDCR FAULT,¿ ALARM CONTINUOUSLY. DEVICE WAS NOT ON A PATIENT AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19530456 ↗MalfunctionMay 9, 2024No Device Output; No Device Output
IT WAS REPORTED TO VYAIRE MEDICAL THE VELA VENTILATOR SHOWED THE ALARM XDCR (TRANSDUCER) FAIL. THE TRANSDUCER CALIBRATIONS WERE PERFORMED BUT THEY DID NOT PASS.NO PATIENT WAS INVOLVED ON THIS FAILURE, IT HAPPENED WHEN DURING OVP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19280352 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.