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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, uterine contraction, external (for use in clinic)
Product CodeHFM
Regulation Number 884.2720
Device Class 2


Premarket Reviews
ManufacturerDecision
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 2 2
2020 1 1
2021 2 2
2022 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 3 3
Device Alarm System 2 2
No Audible Prompt/Feedback 2 2
Device Operates Differently Than Expected 1 1
Improper Device Output 1 1
Device Fell 1 1
Defective Alarm 1 1
No Display/Image 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Known Impact Or Consequence To Patient 2 2
Death, Intrauterine Fetal 1 1
Therapeutic Effects, Unexpected 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pacific Medical Group Inc. II Feb-12-2020
2 Pacific Medical Group Inc. II Feb-04-2020
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