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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
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
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 81 81
Incorrect Measurement 26 26
Defective Alarm 23 23
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Material Integrity Problem 18 18
No Apparent Adverse Event 16 16
Adverse Event Without Identified Device or Use Problem 16 16
Insufficient Information 16 16
High Readings 15 15
Device Alarm System 14 14
Appropriate Term/Code Not Available 8 8
Electrical /Electronic Property Problem 7 7
No Visual Prompts/Feedback 6 6
Crack 5 5
Circuit Failure 4 4
Overheating of Device 4 4
Audible Prompt/Feedback Problem 4 4
Unable to Obtain Readings 4 4
Protective Measures Problem 3 3
Electrical Shorting 3 3
Use of Device Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Failure to Sense 3 3
Failure to Transmit Record 3 3
Output Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Patient Device Interaction Problem 2 2
No Device Output 2 2
Device Displays Incorrect Message 2 2
Improper or Incorrect Procedure or Method 2 2
False Alarm 2 2
Operating System Becomes Nonfunctional 2 2
Erratic or Intermittent Display 2 2
Inaudible or Unclear Audible Prompt/Feedback 2 2
Image Display Error/Artifact 2 2
Noise, Audible 1 1
Radiofrequency Interference (RFI) 1 1
Loss of or Failure to Bond 1 1
Intermittent Communication Failure 1 1
Inappropriate Audible Prompt/Feedback 1 1
Signal Artifact/Noise 1 1
Self-Activation or Keying 1 1
Disconnection 1 1
Connection Problem 1 1
Application Network Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Break 1 1
Computer Software Problem 1 1
Low Audible Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 260 260
Insufficient Information 38 38
No Patient Involvement 18 18
No Consequences Or Impact To Patient 11 11
Death 7 7
Fetal Distress 6 6
No Known Impact Or Consequence To Patient 5 5
Skin Burning Sensation 4 4
Burn, Thermal 3 3
Cardiac Arrest 3 3
Burn(s) 3 3
Superficial (First Degree) Burn 2 2
Loss Of Pulse 2 2
Asystole 2 2
Patient Problem/Medical Problem 1 1
Brain Injury 1 1
Not Applicable 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Head Injury 1 1
Injury 1 1
Bradycardia 1 1
Anxiety 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Respiratory Problem 1 1
Hemorrhage/Bleeding 1 1
Therapeutic Effects, Unexpected 1 1
Hypoxia in Utero 1 1
Low Oxygen Saturation 1 1
Death, Intrauterine Fetal 1 1
Unspecified Reproductive System or Breast Problem 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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