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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, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP/ EXCEL MEDICAL
  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 1
CASANA CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGE HEALTHCARE ISRAEL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
COSINUSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EMPATICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
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
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
2021 188 188
2022 168 173
2023 179 179
2024 120 120
2025 184 184
2026 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Shutdown 149 151
Incorrect Measurement 76 77
Sensing Intermittently 66 66
No Audible Alarm 54 54
Failure to Power Up 46 46
Incorrect, Inadequate or Imprecise Result or Readings 45 45
Device Alarm System 45 45
Display or Visual Feedback Problem 43 43
Communication or Transmission Problem 37 39
Device Displays Incorrect Message 35 35
Inappropriate or Unexpected Reset 33 33
Sparking 32 32
Intermittent Loss of Power 31 31
Key or Button Unresponsive/not Working 31 31
Pitted 30 30
Application Program Freezes, Becomes Nonfunctional 29 29
Low Readings 22 22
Fire 22 22
Overheating of Device 21 21
Insufficient Information 20 20
Computer Software Problem 17 17
Defective Alarm 14 14
No Display/Image 14 18
Flare or Flash 14 14
Output Problem 13 13
Device Sensing Problem 12 12
Adverse Event Without Identified Device or Use Problem 11 11
High Readings 11 11
No Audible Prompt/Feedback 11 11
Unable to Obtain Readings 11 11
Defibrillation/Stimulation Problem 11 11
Smoking 11 11
Detachment of Device or Device Component 9 9
Electrical Shorting 8 8
Application Program Problem 8 8
Erratic or Intermittent Display 8 8
Thermal Decomposition of Device 8 8
Operating System Becomes Nonfunctional 7 7
Wireless Communication Problem 7 7
Measurement System Incompatibility 6 6
Electrical /Electronic Property Problem 6 6
Loose or Intermittent Connection 5 5
Premature Discharge of Battery 5 5
Break 5 5
Unintended Electrical Shock 5 5
Explosion 5 5
Erratic Results 5 5
Material Split, Cut or Torn 4 4
Material Deformation 4 4
Protective Measures Problem 4 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 870 873
Insufficient Information 63 63
Electric Shock 8 8
Cardiac Arrest 7 7
Burn(s) 4 4
Erythema 2 2
Discomfort 2 4
Laceration(s) 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
No Consequences Or Impact To Patient 2 2
Bruise/Contusion 2 2
Non specific EKG/ECG Changes 1 1
Encephalopathy 1 1
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Brain Injury 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
Valvular Stenosis 1 3
Asystole 1 1
Shock 1 1
Swelling/ Edema 1 1
Myocardial Infarction 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 Covidien LLC II Mar-11-2026
8 Edan Diagnostics II Jan-22-2026
9 GE Medical Systems, LLC II Jan-15-2025
10 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-30-2024
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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