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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)
Product CodeMWI
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMZETTA TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ANALOG DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ATHENA GTX
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAPSULE SURVEILLANCE TECHNOLOGIES, SAS /CAPSULE TECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAPSULE TECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 1
CAPSULE TECHNOLOGIE SAS
  SUBSTANTIALLY EQUIVALENT 2
CASANA CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGE HEALTHCARE ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIGICARE BIOMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
DYNOSENSE CORP.
  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 2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LD TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
MEDOPAD INC
  SUBSTANTIALLY EQUIVALENT 1
MEDWAND SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MULTISENSOR DIAGNOSTICS (DBA AIDAR HEALTH)
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORDINATRUM SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
PERAHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
STASIS LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TALIS CLINICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOCARE, INC.
  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
2019 169 169
2020 110 110
2021 188 188
2022 168 168
2023 179 179
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 94 94
High Readings 53 53
Sensing Intermittently 50 50
Unexpected Shutdown 43 43
Inappropriate or Unexpected Reset 41 41
Device Alarm System 39 39
No Audible Alarm 38 38
Incorrect, Inadequate or Imprecise Result or Readings 38 38
Pitted 29 29
Output Problem 26 26
Application Program Freezes, Becomes Nonfunctional 26 26
Sparking 24 24
No Display/Image 20 20
Low Readings 19 19
Insufficient Information 19 19
Therapeutic or Diagnostic Output Failure 18 18
Fire 16 16
Computer Software Problem 16 16
Overheating of Device 15 15
Defective Alarm 14 14
Unable to Obtain Readings 14 14
Flare or Flash 14 14
Display or Visual Feedback Problem 13 13
Defibrillation/Stimulation Problem 12 12
Smoking 11 11
Failure to Power Up 11 11
No Audible Prompt/Feedback 10 10
Application Program Problem 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Operating System Becomes Nonfunctional 8 8
Device Sensing Problem 7 7
Electrical Shorting 7 7
Battery Problem 7 7
Defective Device 7 7
Device Displays Incorrect Message 7 7
Communication or Transmission Problem 6 6
Electrical /Electronic Property Problem 6 6
Loose or Intermittent Connection 6 6
Computer Operating System Problem 6 6
Measurement System Incompatibility 6 6
Unintended Electrical Shock 5 5
Appropriate Term/Code Not Available 5 5
Melted 5 5
Premature Discharge of Battery 5 5
Break 5 5
Failure to Charge 5 5
Circuit Failure 4 4
Erratic or Intermittent Display 4 4
Data Problem 4 4
Device Fell 4 4
Charging Problem 4 4
Material Deformation 4 4
Detachment of Device or Device Component 3 3
Wireless Communication Problem 3 3
Explosion 3 3
Temperature Problem 3 3
Delayed Alarm 3 3
Thermal Decomposition of Device 3 3
Defective Component 3 3
Failure to Analyze Signal 3 3
Self-Activation or Keying 3 3
Failure to Read Input Signal 3 3
Improper or Incorrect Procedure or Method 2 2
Inappropriate Audible Prompt/Feedback 2 2
Difficult or Delayed Activation 2 2
Date/Time-Related Software Problem 2 2
Arcing 2 2
Component or Accessory Incompatibility 2 2
Display Difficult to Read 2 2
Intermittent Continuity 2 2
Material Frayed 2 2
Image Display Error/Artifact 2 2
Device Emits Odor 2 2
No Device Output 2 2
Protective Measures Problem 2 2
Noise, Audible 2 2
Device Markings/Labelling Problem 2 2
Inadequate User Interface 2 2
Unintended Application Program Shut Down 2 2
Audible Prompt/Feedback Problem 2 2
Delayed Program or Algorithm Execution 2 2
Incomplete or Inadequate Connection 1 1
Failure to Deflate 1 1
Key or Button Unresponsive/not Working 1 1
Program or Algorithm Execution Problem 1 1
Material Integrity Problem 1 1
Output below Specifications 1 1
Connection Problem 1 1
Excessive Cooling 1 1
Failure of Device to Self-Test 1 1
Device-Device Incompatibility 1 1
Electrical Power Problem 1 1
Complete Loss of Power 1 1
Intermittent Loss of Power 1 1
Material Split, Cut or Torn 1 1
No Apparent Adverse Event 1 1
Power Problem 1 1
Pressure Problem 1 1
Patient Data Problem 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 496 496
No Consequences Or Impact To Patient 159 159
No Known Impact Or Consequence To Patient 67 67
Insufficient Information 60 60
No Patient Involvement 19 19
Cardiac Arrest 7 7
Electric Shock 6 6
Death 5 5
Burn(s) 3 3
No Information 3 3
Injury 3 3
No Code Available 2 2
Superficial (First Degree) Burn 2 2
Partial thickness (Second Degree) Burn 1 1
Valvular Stenosis 1 1
Asystole 1 1
Unspecified Heart Problem 1 1
Respiratory Arrest 1 1
Skin Disorders 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Cardiopulmonary Arrest 1 1
Cyanosis 1 1
Loss Of Pulse 1 1
Vascular System (Circulation), Impaired 1 1
Discomfort 1 1
Non specific EKG/ECG Changes 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Seizures 1 1
Shock 1 1
Skin Discoloration 1 1
Swelling 1 1
Ventricular Fibrillation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Sep-12-2023
2 Infinium Medical, Inc II Jul-02-2019
3 Mindray DS USA, Inc. dba Mindray North America II Oct-29-2019
4 Philips North America, LLC II Aug-14-2020
5 Philips North America, LLC II Jun-02-2020
6 Philips North America, LLC II Mar-31-2020
7 Philips North America Llc II Oct-04-2022
8 Philips North America Llc II May-06-2022
9 Philips North America Llc II Apr-29-2021
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