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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device uterine electromyographic monitor
Regulation Description External uterine contraction monitor and accessories.
Definition The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
Product CodeOSP
Regulation Number 884.2720
Device Class 2


Premarket Reviews
ManufacturerDecision
OBMEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Alarm 1 1
Device Sensing Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Patient Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abrasion 1 1
Skin Irritation 1 1
Discharge 1 1
Superficial (First Degree) Burn 1 1
Insufficient Information 1 1
Death 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Mar-14-2018
2 MONICA HEALTHCARE LTD II May-25-2017
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