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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


Premarket Reviews
ManufacturerDecision
NEOVENTA MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 25 25
2021 33 33
2022 27 27
2023 8 8
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Handling Problem 17 17
Insufficient Information 16 16
Material Fragmentation 12 12
Adverse Event Without Identified Device or Use Problem 10 10
Detachment of Device or Device Component 7 7
Break 5 5
Positioning Problem 5 5
Difficult to Remove 4 4
Use of Device Problem 4 4
Entrapment of Device 3 3
Separation Failure 3 3
Defective Component 2 2
Unable to Obtain Readings 2 2
Component Missing 2 2
Difficult or Delayed Separation 2 2
Connection Problem 2 2
Signal Artifact/Noise 1 1
Disconnection 1 1
Fitting Problem 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Incorrect Measurement 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Post Operative Wound Infection 31 31
No Clinical Signs, Symptoms or Conditions 18 18
Abrasion 10 10
No Known Impact Or Consequence To Patient 6 6
Needle Stick/Puncture 6 6
Foreign Body In Patient 5 5
Insufficient Information 5 5
Head Injury 4 4
Localized Skin Lesion 3 3
Laceration(s) 3 3
Device Embedded In Tissue or Plaque 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Tissue Injury 2 2
No Consequences Or Impact To Patient 2 2
Vessel Or Plaque, Device Embedded In 1 1
Abdominal Pain 1 1
Unspecified Infection 1 1
Nausea 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Burn, Thermal 1 1
Blood Loss 1 1
Post Traumatic Wound Infection 1 1
Injury 1 1
Vomiting 1 1
Hair Loss 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1
Meningitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America Llc II Jan-06-2023
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