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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
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 1
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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unexpected Shutdown 68 68
Incorrect Measurement 62 62
Sensing Intermittently 50 50
No Audible Alarm 47 47
Device Alarm System 37 37
Inappropriate or Unexpected Reset 34 34
Incorrect, Inadequate or Imprecise Result or Readings 33 33
Pitted 30 30
Sparking 28 28
Application Program Freezes, Becomes Nonfunctional 27 27
Fire 19 19
Output Problem 18 18
Insufficient Information 17 17
No Display/Image 17 17
Failure to Power Up 16 16
Overheating of Device 16 16
Defective Alarm 15 15
Computer Software Problem 15 15
Flare or Flash 14 14
Unable to Obtain Readings 14 14
No Audible Prompt/Feedback 14 14
Low Readings 13 13
Display or Visual Feedback Problem 13 13
Defibrillation/Stimulation Problem 12 12
Therapeutic or Diagnostic Output Failure 12 12
Adverse Event Without Identified Device or Use Problem 10 10
Smoking 10 10
High Readings 10 10
Application Program Problem 9 9
Electrical Shorting 7 7
Communication or Transmission Problem 7 7
Operating System Becomes Nonfunctional 7 7
Device Displays Incorrect Message 6 6
Measurement System Incompatibility 6 6
Electrical /Electronic Property Problem 6 6
Unintended Electrical Shock 6 6
Loose or Intermittent Connection 6 6
Failure to Charge 5 5
Premature Discharge of Battery 5 5
Break 5 5
Explosion 5 5
Melted 5 5
Device Sensing Problem 4 4
Circuit Failure 4 4
Wireless Communication Problem 4 4
Appropriate Term/Code Not Available 4 4
Battery Problem 4 4
Erratic or Intermittent Display 4 4
Charging Problem 4 4
Material Split, Cut or Torn 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 589 589
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
Laceration(s) 2 2
Discomfort 2 2
Superficial (First Degree) Burn 2 2
No Information 2 2
Unspecified Tissue Injury 2 2
Seizures 1 1
Shock 1 1
Skin Discoloration 1 1
Swelling 1 1
Ventricular Fibrillation 1 1
Loss Of Pulse 1 1
Partial thickness (Second Degree) Burn 1 1
Valvular Stenosis 1 1
No Code Available 1 1
Asystole 1 1
Unspecified Heart Problem 1 1
Respiratory Arrest 1 1
Arrhythmia 1 1
Non specific EKG/ECG Changes 1 1
Encephalopathy 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Disorders 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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