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ExSpiron 1Xi

Respiratory Motion Inc. · Model Monitor · UDI-DI 00851540007000

BZKBZQ Prescription
10
510(k) clearances
136
Adverse events (2 deaths)
3
Recalls
38
Facilities

Description

A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron 1Xi PadSet via the ExSpiron 1Xi Patient Cable, the ExSpiron 1Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 1Xi Monitor can be integrated into a medical facility's nurse call system via the ExSpiron 1Xi Nurse Call Module.

Recalls

DateFirmReason
2017-12-01Mindray DS USA, Inc. dba Mindray North AmericaThe firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
2011-07-29Respironics Novametrix, LLC.Pressure lines maybe occluded and display incorrect tidal volumes.
2011-07-29Respironics Novametrix, LLC.Pressure lines maybe occluded and display incorrect tidal volumes.

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Data 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.