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Catalog Number 3043 |
Device Problems
Unable to Obtain Readings (1516); 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 11/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1 reporter phone: (b)(6) e2: incorrect due to system limitations.E2 correct response: n - initial reporter was a quality specialist.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 there was a failure during the read.There was an incorrect read of the spo2.The type y neonatal oximetry sensors stopped working within a short period of time.The spo2 values were inconsistent with the patient's condition.The event occurred during patient use when the failure was detected, however there was no one harmed as result of the event.
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Manufacturer Narrative
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Product was not returned, and no photographic evidence provided to aid in this investigation.As a result, product evaluation and problem confirmation cannot be performed.The exact cause could not be determined; however, based on the reported problem, the most probable cause could be improper patient attachment tape use.Item is a purchased finished good, the device history record (dhr) is at the supplier and not readily available for review.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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