Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE , LTD.
  SUBSTANTIALLY EQUIVALENT 2
PERIGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 71 71
2022 87 88
2023 69 69
2024 174 174
2025 101 101

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 124 124
No Audible Prompt/Feedback 106 106
Incorrect Measurement 77 77
Incorrect, Inadequate or Imprecise Result or Readings 35 35
High Readings 33 34
High Test Results 29 29
Defective Alarm 25 25
Insufficient Information 20 20
Unable to Obtain Readings 16 16
Erratic Results 12 12
Adverse Event Without Identified Device or Use Problem 9 9
Device Alarm System 9 9
Appropriate Term/Code Not Available 6 6
Audible Prompt/Feedback Problem 6 6
No Visual Prompts/Feedback 6 6
Overheating of Device 5 5
Signal Artifact/Noise 3 3
Failure to Transmit Record 3 3
Protective Measures Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Erratic or Intermittent Display 3 3
Inaudible or Unclear Audible Prompt/Feedback 3 3
Output Problem 3 3
Use of Device Problem 3 3
No Device Output 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Circuit Failure 2 2
Low Readings 2 2
False Alarm 2 2
Patient Device Interaction Problem 2 2
Image Display Error/Artifact 2 2
Failure to Sense 2 2
Failure to Power Up 1 1
Inaccurate Flow Rate 1 1
Imprecision 1 1
Volume Accuracy Problem 1 1
Fire 1 1
Device Handling Problem 1 1
Disconnection 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Poor Quality Image 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Unintended Electrical Shock 1 1
Low Audible Alarm 1 1
Computer Software Problem 1 1
Failure to Clean Adequately 1 1
Energy Output Problem 1 1
Device Fell 1 1
Application Network Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 436 437
Insufficient Information 46 46
Fetal Distress 7 7
Burn(s) 4 4
Hypoxia in Utero 4 4
Skin Burning Sensation 4 4
Superficial (First Degree) Burn 2 2
Cardiac Arrest 2 2
Asystole 2 2
Hypoxia 2 2
Hemorrhage/Bleeding 2 2
Encephalopathy 1 1
Uterine Perforation 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Head Injury 1 1
Burn, Thermal 1 1
Respiratory Acidosis 1 1
Thrombosis/Thrombus 1 1
Bradycardia 1 1
Tachycardia 1 1
Unspecified Respiratory Problem 1 1
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1
Bruise/Contusion 1 1
Unspecified Reproductive System or Breast Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America Llc II Jun-28-2024
-
-