Model Number 989803137631 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Serial number unknown.A follow-up report will be submitted once the investigation is complete.
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Event Description
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It was reported that the fetal scalp electrode broke during use.
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Manufacturer Narrative
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The fetal scalp electrode was not returned for analysis therefore the cause of the reported malfunction could not be determined.The fragment of the fetal scalp electrode was identified and removed by the infant's parents without medical intervention.The baby was also seen by a pediatrician at a regularly scheduled appointment without further incident.
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Event Description
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It was reported that the fetal scalp electrode broke during use and was removed without medical intervention.
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Search Alerts/Recalls
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