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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 4
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 30 30
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 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Prompt/Feedback 86 86
No Audible Alarm 83 83
Device Operates Differently Than Expected 42 42
Adverse Event Without Identified Device or Use Problem 33 33
Incorrect Measurement 30 30
Incorrect, Inadequate or Imprecise Result or Readings 26 26
Insufficient Information 26 26
Defective Alarm 25 25
Material Integrity Problem 19 19
Device Alarm System 18 18
High Readings 17 17
No Apparent Adverse Event 16 16
Defective Device 13 13
Appropriate Term/Code Not Available 10 10
Noise, Audible 8 8
Electrical /Electronic Property Problem 7 7
Unable to Obtain Readings 7 7
Incorrect Or Inadequate Test Results 6 6
Crack 6 6
No Visual Prompts/Feedback 6 6
Overheating of Device 5 5
Output Problem 5 5
Failure to Advance 5 5
Protective Measures Problem 5 5
Use of Device Problem 4 4
Circuit Failure 4 4
No Device Output 4 4
Component Falling 4 4
Audible Prompt/Feedback Problem 4 4
Failure to Transmit Record 4 4
Improper or Incorrect Procedure or Method 4 4
Device Displays Incorrect Message 4 4
Electrical Shorting 3 3
Device Inoperable 3 3
Communication or Transmission Problem 3 3
Erratic or Intermittent Display 3 3
Invalid Sensing 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Failure to Sense 3 3
Patient-Device Incompatibility 2 2
Connection Problem 2 2
Incorrect Interpretation of Signal 2 2
Out-Of-Box Failure 2 2
Detachment Of Device Component 2 2
Fire 2 2
Inaudible or Unclear Audible Prompt/Feedback 2 2
Break 2 2
Patient Device Interaction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Image Display Error/Artifact 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 261 261
No Known Impact Or Consequence To Patient 43 43
Death 38 38
Insufficient Information 38 38
No Patient Involvement 21 21
No Consequences Or Impact To Patient 19 19
Fetal Distress 14 14
Death, Intrauterine Fetal 10 10
Not Applicable 10 10
No Information 7 7
Burn(s) 7 7
Injury 6 6
No Code Available 5 5
Cardiac Arrest 5 5
Erythema 5 5
Bradycardia 5 5
Skin Burning Sensation 4 4
Encephalopathy 3 3
Superficial (First Degree) Burn 3 3
Patient Problem/Medical Problem 3 3
Misdiagnosis 3 3
Hypoxia 3 3
Burn, Thermal 3 3
Loss Of Pulse 3 3
Low Oxygen Saturation 2 2
Complaint, Ill-Defined 2 2
Hypoxia in Utero 2 2
Brain Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Inflammation 2 2
Tissue Damage 2 2
Asystole 2 2
Unspecified Reproductive System or Breast Problem 1 1
Hemorrhage/Bleeding 1 1
Therapeutic Effects, Unexpected 1 1
Loss of consciousness 1 1
Unspecified Respiratory Problem 1 1
Skin Tears 1 1
Anxiety 1 1
Tachycardia 1 1
Asphyxia 1 1
Cardiopulmonary Arrest 1 1
Skin Erosion 1 1
Rash 1 1
Neurological Deficit/Dysfunction 1 1
Decreased Apgar 1 1
Abrasion 1 1
Head Injury 1 1
Ischemia 1 1
Bone Fracture(s) 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
6 Philips North America Llc II Jun-28-2024
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