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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: initial reporter phone number: (b)(6).E2: incorrect due to system limitations.E2 - correct response: n - initial reporter is quality specialist, non-healthcare professional.H3 - other: device has not been returned for investigation.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 sample is available for evaluation.The event occurred during patient use.There was no patient harm/adverse event.
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Manufacturer Narrative
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Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The exact cause could not be determined; however, based on the reported problem, the most probable cause could be improper patient attachment tape use.A device history report (dhr) review could not be performed as the dhr is at the supplier.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Search Alerts/Recalls
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