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Model Number 1040000 |
Device Problems
Failure to Recalibrate (1517); Inaccurate Delivery (2339); Insufficient Information (3190)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 02/18/2021 |
Event Type
Injury
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Event Description
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The manufacturer received information alleging a ventilator was not delivering oxygen properly and a patient's blood oxygen saturation dropped while on the device.The patient was placed on a different ventilator in response to the event.A request has been made to the customer to have the device returned to the manufacturer's quality product investigation laboratory; however, at this time the device has yet to be returned for evaluation, and we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Manufacturer Narrative
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The manufacturer previously reported receiving information alleging a ventilator was not delivering oxygen properly and a patient's blood oxygen saturation dropped while on the device.The ventilator was exchanged for another device in response to the event.The device was returned to the manufacturer's quality product investigation laboratory for evaluation, and the customer's complaint was confirmed.During the evaluation, the device failed steps during testing and a "service required" code was found in the ventilator's downloaded event log.The manufacturer concludes the root cause is related to a failure of the c27 component on the device's interface board.The device's interface board needs replaced to address the issue.The device failed steps during testing due to an issue related to the device's sensor board.These test step failures were not related to the reported event.The device's sensor board needs replaced to address the issues.
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Search Alerts/Recalls
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