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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 1
ETIOMETRY, INC.
  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
  1.  K230214  Huma RPM (RPM)
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 168 168
2023 179 179
2024 120 120
2025 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Shutdown 71 71
Incorrect Measurement 62 62
No Audible Alarm 53 53
Sensing Intermittently 51 51
Device Alarm System 42 42
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Inappropriate or Unexpected Reset 34 34
Pitted 30 30
Sparking 28 28
Application Program Freezes, Becomes Nonfunctional 28 28
Fire 19 19
Output Problem 18 18
No Display/Image 17 17
Insufficient Information 17 17
Overheating of Device 17 17
Computer Software Problem 16 16
Failure to Power Up 16 16
Defective Alarm 15 15
No Audible Prompt/Feedback 14 14
Unable to Obtain Readings 14 14
Flare or Flash 14 14
Display or Visual Feedback Problem 14 14
Low Readings 13 13
Defibrillation/Stimulation Problem 12 12
Therapeutic or Diagnostic Output Failure 12 12
High Readings 10 10
Smoking 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Application Program Problem 9 9
Electrical Shorting 7 7
Thermal Decomposition of Device 7 7
Communication or Transmission Problem 7 7
Operating System Becomes Nonfunctional 7 7
Unintended Electrical Shock 6 6
Electrical /Electronic Property Problem 6 6
Loose or Intermittent Connection 6 6
Measurement System Incompatibility 6 6
Device Displays Incorrect Message 6 6
Premature Discharge of Battery 5 5
Explosion 5 5
Melted 5 5
Break 5 5
Erratic or Intermittent Display 5 5
Failure to Charge 5 5
Device Sensing Problem 4 4
Battery Problem 4 4
Charging Problem 4 4
Material Deformation 4 4
Appropriate Term/Code Not Available 4 4
Wireless Communication Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 614 614
Insufficient Information 62 62
No Consequences Or Impact To Patient 48 48
No Known Impact Or Consequence To Patient 28 28
No Patient Involvement 10 10
Cardiac Arrest 8 8
Electric Shock 7 7
Death 5 5
Burn(s) 3 3
Superficial (First Degree) Burn 2 2
No Information 2 2
Discomfort 2 2
Laceration(s) 2 2
Unspecified Tissue Injury 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
Skin Discoloration 1 1
Ventricular Fibrillation 1 1
Loss Of Pulse 1 1
Erythema 1 1
Swelling 1 1
Valvular Stenosis 1 1
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 Oct-17-2024
6 GE Medical Systems, LLC II Jan-15-2025
7 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-30-2024
8 Philips North America, LLC II Aug-14-2020
9 Philips North America, LLC II Jun-02-2020
10 Philips North America, LLC II Mar-31-2020
11 Philips North America Llc II Oct-04-2022
12 Philips North America Llc II May-06-2022
13 Philips North America Llc II Apr-29-2021
14 Spectrum Medical Ltd. II Apr-29-2025
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