Model Number 989803137631 |
Device Problem
Difficult to Remove (1528)
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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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A follow-up report will be submitted upon completion of the investigation.We are still in the process of assessing the incident.The electrodes were discarded.
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Event Description
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The customer reported they could not remove the fetal electrode probe from the infant's scalp.Emergent care was provided by the doctor and the tip was removed from the infant's scalp and discarded.
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Manufacturer Narrative
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The customer reported an intern could not remove the fetal electrode probe from the infant's scalp and that this was the intern's third time having this problem.The attending physician cut the baby's scalp in order to remove the fetal spiral electrode.The fetal spiral assembly was discarded and not available for evaluation.As the result of this event, the customer was provided training on the use of the fetal spiral electrode by a philips representative.It was observed that the intern was applying the electrode with more than one turn and the plastic tip was embossing into the baby¿s scalp.As a result, we are not considering this to be a product malfunction.The ifu for the fse (p/n (b)(4) states in a warning not to over rotate the fse.The date of the incident was not provided.
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Search Alerts/Recalls
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