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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
Product CodeHGM
Regulation Number 884.2740
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED INSTRUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
AIRSTRIP TECHNOLOGIES, LP
  SUBSTANTIALLY EQUIVALENT 2
ALERTWATCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
BLOOM TECHNOLOGIES NV
  SUBSTANTIALLY EQUIVALENT 1
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 2
CIVNET COMMUNICATION LTD
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL COMPUTER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATEX OHMEDA
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
FARUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE INTEGRATED IT SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG BIOLIGHT MEDITECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNTLEIGH HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
MCKESSON INFORMATION SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MINDCHILD MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
OB TOOLS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
  SUBSTANTIALLY EQUIVALENT 1
SENSE4BABY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUNRAY MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WIPRO GE HEALTHCARE PRIVATE, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 29 29
2015 44 44
2016 17 17
2017 27 27
2018 30 30
2019 41 41
2020 19 19
2021 71 71
2022 87 87
2023 69 69
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Prompt/Feedback 83 83
No Audible Alarm 67 67
Device Operates Differently Than Expected 42 42
Adverse Event Without Identified Device or Use Problem 33 33
Insufficient Information 24 24
Material Integrity Problem 19 19
Defective Alarm 19 19
Device Alarm System 17 17
Incorrect Measurement 17 17
No Apparent Adverse Event 16 16
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Defective Device 13 13
Noise, Audible 8 8
Electrical /Electronic Property Problem 7 7
Crack 6 6
Unable to Obtain Readings 6 6
Incorrect Or Inadequate Test Results 6 6
Output Problem 5 5
Protective Measures Problem 5 5
Failure to Advance 5 5
Appropriate Term/Code Not Available 4 4
Audible Prompt/Feedback Problem 4 4
Device Displays Incorrect Message 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Failure to Transmit Record 4 4
No Device Output 4 4
Overheating of Device 4 4
Component Falling 4 4
Circuit Failure 4 4
Erratic or Intermittent Display 3 3
Invalid Sensing 3 3
Device Inoperable 3 3
Failure to Sense 3 3
High Readings 3 3
Communication or Transmission Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Electrical Shorting 3 3
Improper Device Output 2 2
Operating System Becomes Nonfunctional 2 2
Therapeutic or Diagnostic Output Failure 2 2
Patient Device Interaction Problem 2 2
Connection Problem 2 2
Device Sensing Problem 2 2
Patient-Device Incompatibility 2 2
Break 2 2
Incorrect Interpretation of Signal 2 2
Out-Of-Box Failure 2 2
Detachment Of Device Component 2 2
Signal Artifact/Noise 2 2
False Alarm 2 2
Loss of Power 2 2
Fire 2 2
Image Display Error/Artifact 2 2
Imprecision 1 1
Loose or Intermittent Connection 1 1
Inaccurate Flow Rate 1 1
Poor Quality Image 1 1
Device Emits Odor 1 1
Energy Output Problem 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Over-Sensing 1 1
Pitted 1 1
Power Conditioning Problem 1 1
Low Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Display or Visual Feedback Problem 1 1
False Device Output 1 1
False Positive Result 1 1
Computer Software Problem 1 1
Disconnection 1 1
Radiofrequency Interference (RFI) 1 1
Device Contamination with Body Fluid 1 1
Material Perforation 1 1
Inappropriate Audible Prompt/Feedback 1 1
Self-Activation or Keying 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Application Network Problem 1 1
Application Program Problem 1 1
Calibration Problem 1 1
High Test Results 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Difficult to Advance 1 1
Low Readings 1 1
Loss of Data 1 1
Detachment of Device or Device Component 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Intermittent Communication Failure 1 1
Failure to Clean Adequately 1 1
Missing Information 1 1
Erratic Results 1 1
Misassembly by Users 1 1
Scratched Material 1 1
Patient Data Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 196 196
No Known Impact Or Consequence To Patient 42 42
Death 38 38
Insufficient Information 30 30
No Patient Involvement 21 21
No Consequences Or Impact To Patient 19 19
Fetal Distress 12 12
Death, Intrauterine Fetal 10 10
Not Applicable 10 10
Burn(s) 7 7
No Information 7 7
Injury 6 6
Cardiac Arrest 5 5
Erythema 5 5
Bradycardia 5 5
No Code Available 5 5
Skin Burning Sensation 4 4
Misdiagnosis 3 3
Superficial (First Degree) Burn 3 3
Encephalopathy 3 3
Burn, Thermal 3 3
Loss Of Pulse 3 3
Hypoxia 3 3
Patient Problem/Medical Problem 3 3
Low Oxygen Saturation 2 2
Partial thickness (Second Degree) Burn 2 2
Hypoxia in Utero 2 2
Complaint, Ill-Defined 2 2
Inflammation 2 2
Asystole 2 2
Brain Injury 2 2
Tissue Damage 2 2
Abnormal Blood Gases 1 1
Asphyxia 1 1
Arrhythmia 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Cyanosis 1 1
Tachycardia 1 1
Anxiety 1 1
Respiratory Distress 1 1
Ischemia 1 1
Therapeutic Effects, Unexpected 1 1
Unspecified Respiratory Problem 1 1
Non specific EKG/ECG Changes 1 1
Cardiopulmonary Arrest 1 1
Rash 1 1
Skin Irritation 1 1
Head Injury 1 1
Neurological Deficit/Dysfunction 1 1
Valve Thrombosis 1 1
Loss of consciousness 1 1
Unspecified Reproductive System or Breast Problem 1 1
Decreased Apgar 1 1
Skin Tears 1 1
Skin Erosion 1 1
Hemorrhage/Bleeding 1 1
Low Apgar Score 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare It II Nov-18-2013
2 Pacific Medical Group Inc. II Feb-04-2020
3 Philips Healthcare Inc. II Dec-17-2009
4 Philips Healthcare Inc. II Jun-26-2009
5 Philips Medical Systems, Inc. II Oct-21-2014
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