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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, monitoring, perinatal
Regulation Description Perinatal monitoring system and accessories.
Product CodeHGM
Regulation Number 884.2740
Device Class 2


Premarket Reviews
ManufacturerDecision
BLOOM TECHNOLOGIES NV
  SUBSTANTIALLY EQUIVALENT 1
DATEX OHMEDA
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
PERIGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 19 19
2021 71 71
2022 87 87
2023 69 69
2024 175 175
2025 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 99 99
No Audible Prompt/Feedback 94 94
Incorrect Measurement 67 67
High Readings 32 32
Incorrect, Inadequate or Imprecise Result or Readings 30 30
High Test Results 29 29
Defective Alarm 24 24
Insufficient Information 20 20
Unable to Obtain Readings 13 13
Device Alarm System 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Appropriate Term/Code Not Available 7 7
Overheating of Device 6 6
No Visual Prompts/Feedback 6 6
Audible Prompt/Feedback Problem 5 5
Erratic or Intermittent Display 4 4
Erratic Results 3 3
Failure to Transmit Record 3 3
Failure to Sense 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Use of Device Problem 3 3
Output Problem 3 3
Inaudible or Unclear Audible Prompt/Feedback 3 3
Protective Measures Problem 3 3
Low Readings 3 3
No Device Output 2 2
Device Displays Incorrect Message 2 2
Patient Device Interaction Problem 2 2
Image Display Error/Artifact 2 2
False Alarm 2 2
Electrical /Electronic Property Problem 2 2
Signal Artifact/Noise 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Circuit Failure 2 2
Noise, Audible 1 1
Radiofrequency Interference (RFI) 1 1
Intermittent Communication Failure 1 1
Inappropriate Audible Prompt/Feedback 1 1
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
False Positive Result 1 1
Application Network Problem 1 1
Computer Software Problem 1 1
Low Audible Alarm 1 1
Disconnection 1 1
Missing Information 1 1
No Apparent Adverse Event 1 1
Detachment of Device or Device Component 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 376 376
Insufficient Information 47 47
Fetal Distress 7 7
Skin Burning Sensation 4 4
Death 3 3
Burn, Thermal 3 3
Burn(s) 3 3
Superficial (First Degree) Burn 2 2
Cardiac Arrest 2 2
Asystole 2 2
No Consequences Or Impact To Patient 2 2
Uterine Perforation 1 1
Not Applicable 1 1
Brain Injury 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Head Injury 1 1
No Known Impact Or Consequence To Patient 1 1
Respiratory Acidosis 1 1
Injury 1 1
No Patient Involvement 1 1
Bradycardia 1 1
Unspecified Respiratory Problem 1 1
Hemorrhage/Bleeding 1 1
Hypoxia in Utero 1 1
Low Oxygen Saturation 1 1
Unspecified Reproductive System or Breast Problem 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pacific Medical Group Inc. II Feb-04-2020
2 Philips North America Llc II Jun-28-2024
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