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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeMWI
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMC HEALTH
  SUBSTANTIALLY EQUIVALENT 1
ANALOG DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ANALOG DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATHENA GTX
  SUBSTANTIALLY EQUIVALENT 1
ATHENA GTX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAPSULE SURVEILLANCE TECHNOLOGIES, SAS /CAPSULE TECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAPSULE TECHNOLOGIE SAS
  SUBSTANTIALLY EQUIVALENT 2
CASANA CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGE HEALTHCARE ISRAEL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EKO DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
EMPATICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
ETIOMETRY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FYSICON BV
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
HAPPY HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
IHEALTH LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LAERDAL MEDICAL AS
  SUBSTANTIALLY EQUIVALENT 1
LD TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
MEDOPAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDWAND SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MULTISENSOR DIAGNOSTICS (DBA AIDAR HEALTH)
  SUBSTANTIALLY EQUIVALENT 1
ORDINATRUM SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TALIS CLINICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WARD 24/7 APS
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZOE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 110 110
2021 188 188
2022 168 173
2023 179 179
2024 120 120
2025 162 162

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Shutdown 99 101
Incorrect Measurement 66 67
Sensing Intermittently 59 59
No Audible Alarm 56 56
Device Alarm System 46 46
Failure to Power Up 46 46
Display or Visual Feedback Problem 44 44
Incorrect, Inadequate or Imprecise Result or Readings 39 39
Communication or Transmission Problem 37 39
Inappropriate or Unexpected Reset 37 37
Device Displays Incorrect Message 36 36
Intermittent Loss of Power 31 31
Key or Button Unresponsive/not Working 31 31
Sparking 30 30
Pitted 30 30
Application Program Freezes, Becomes Nonfunctional 29 29
Fire 21 21
Insufficient Information 20 20
Overheating of Device 19 19
Output Problem 18 18
Defective Alarm 18 18
No Display/Image 17 21
Computer Software Problem 16 16
Low Readings 15 15
No Audible Prompt/Feedback 14 14
Flare or Flash 14 14
Unable to Obtain Readings 14 14
Device Sensing Problem 13 13
Defibrillation/Stimulation Problem 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Smoking 12 12
Therapeutic or Diagnostic Output Failure 12 12
High Readings 11 11
Application Program Problem 10 10
Electrical Shorting 9 9
Thermal Decomposition of Device 9 9
Operating System Becomes Nonfunctional 8 8
Detachment of Device or Device Component 7 7
Loose or Intermittent Connection 7 7
Measurement System Incompatibility 6 6
Wireless Communication Problem 6 6
Unintended Electrical Shock 6 6
Electrical /Electronic Property Problem 6 6
Melted 5 5
Erratic or Intermittent Display 5 5
Premature Discharge of Battery 5 5
Explosion 5 5
Break 5 5
Failure to Charge 5 5
Appropriate Term/Code Not Available 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 736 739
Insufficient Information 64 64
No Consequences Or Impact To Patient 48 48
No Known Impact Or Consequence To Patient 28 28
No Patient Involvement 10 10
Electric Shock 8 8
Cardiac Arrest 8 8
Death 5 5
Burn(s) 3 3
Erythema 3 3
Superficial (First Degree) Burn 2 2
No Information 2 2
Discomfort 2 4
Laceration(s) 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
Bruise/Contusion 2 2
Non specific EKG/ECG Changes 1 1
Encephalopathy 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Hypersensitivity/Allergic reaction 1 1
Seizures 1 1
No Code Available 1 1
Respiratory Arrest 1 1
Skin Disorders 1 1
Easy Bruising 1 1
Skin Discoloration 1 1
Ventricular Fibrillation 1 1
Loss Of Pulse 1 1
Swelling 1 1
Valvular Stenosis 1 3
Asystole 1 1
Shock 1 1
Swelling/ Edema 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Heart Problem 1 1
Low Oxygen Saturation 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 A L I Technologies Ltd II Jan-16-2025
2 Baxter Healthcare Corporation II Apr-15-2025
3 Baxter Healthcare Corporation II Apr-14-2025
4 Baxter Healthcare Corporation II Sep-12-2023
5 CHANGE HEALTHCARE CANADA COMPANY II Jul-02-2025
6 CHANGE HEALTHCARE CANADA COMPANY II Oct-17-2024
7 GE Medical Systems, LLC II Jan-15-2025
8 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-30-2024
9 Philips North America, LLC II Aug-14-2020
10 Philips North America, LLC II Jun-02-2020
11 Philips North America, LLC II Mar-31-2020
12 Philips North America Llc II Oct-04-2022
13 Philips North America Llc II May-06-2022
14 Philips North America Llc II Apr-29-2021
15 Spectrum Medical Ltd. II Apr-29-2025
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