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3100A HFOV
VYAIRE MEDICAL, INC. · Model 773996 · UDI-DI 50190752155488
LSZ
Prescription
0
510(k) clearances
3,097
Adverse events (42 deaths)
7
Recalls
5
Facilities
Description
Flexible Patient Circuit, 3100A MR850 in Heated Environment (Box of 4)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-27 | Vyaire Medical | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S. |
| 2023-10-27 | Vyaire Medical | Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S. |
| 2022-11-02 | Bunnell, Inc. | Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect n |
| 2012-11-19 | Bunnell, Inc. | Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunn |
| 2010-10-25 | Bunnell, Inc. | Product software coding error may compromise patient safety. |
| 2010-10-25 | Bunnell, Inc. | Product software coding error may compromise patient safety. |
| 2005-04-04 | Bunnell, Inc. | Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature coul |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.