Catalog Number 3301A1 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date of event is unknown; no information has been provided to date.H3: other; device not returned to manufacturer.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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It was reported that the device was giving patients low spo2 in the 80 and when the doctors and nurses send the patient to the emergency room, they get a call from the emergency room stating the spo2 was 93.There was a patient involvement and no patient harm/adverse event reported.
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Search Alerts/Recalls
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