Model Number 3301A1 |
Device Problem
Circuit Failure (1089)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/27/2021 |
Event Type
malfunction
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Event Description
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Information received a smiths medical patient monitoring|bci oximeter handheld - 3301 needs a main new board, according to technician.Unknown if patient involvement occurred.
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Manufacturer Narrative
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Other, other text: one device was returned for investigation.Upon visual inspection, the reported complaint was confirmed and duplicated.After replacing the main board the device was able to to pass a simulation test.
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Manufacturer Narrative
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This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-08947.The report was submitted in error.
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Search Alerts/Recalls
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