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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, circular (spiral), scalp and applicator
Regulation Description Fetal scalp circular (spiral) electrode and applicator.
Product CodeHGP
Regulation Number 884.2675
Device Class 2

Device Problems
Failure to Read Input Signal 9
Human Factors Issue 5
Failure to Disconnect 4
Device Operates Differently Than Expected 4
Material Fragmentation 4
Difficult to Remove 2
Entrapment of Device 1
Unable to Obtain Readings 1
Device Contamination with Chemical or Other Material 1
Electrode 1
Break 1
Shelf Life Exceeded 1
Patient Device Interaction Problem 1
Total Device Problems 35

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America, LLC II May-02-2019

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