Catalog Number P310NUS |
Device Problems
Gas Output Problem (1266); Tidal Volume Fluctuations (1634)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device "failed o2".Patient involvement is unknown.
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Manufacturer Narrative
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Other, other text: b3: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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Additional information was received: there was no patient injury and no medical intervention.
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Search Alerts/Recalls
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