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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
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
  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 3
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LAERDAL MEDICAL AS
  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 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 94 94
High Readings 53 53
Sensing Intermittently 53 53
Unexpected Shutdown 52 52
No Audible Alarm 44 44
Inappropriate or Unexpected Reset 41 41
Device Alarm System 41 41
Incorrect, Inadequate or Imprecise Result or Readings 38 38
Pitted 30 30
Sparking 28 28
Application Program Freezes, Becomes Nonfunctional 28 28
Output Problem 26 26
No Display/Image 20 20
Fire 20 20
Low Readings 19 19
Insufficient Information 19 19
Therapeutic or Diagnostic Output Failure 18 18
Overheating of Device 17 17
Unable to Obtain Readings 16 16
Computer Software Problem 16 16
Flare or Flash 14 14
Display or Visual Feedback Problem 14 14
Defective Alarm 14 14
No Audible Prompt/Feedback 13 13
Failure to Power Up 13 13
Defibrillation/Stimulation Problem 12 12
Smoking 12 12
Adverse Event Without Identified Device or Use Problem 9 9
Operating System Becomes Nonfunctional 8 8
Application Program Problem 8 8
Battery Problem 7 7
Device Displays Incorrect Message 7 7
Electrical Shorting 7 7
Device Sensing Problem 7 7
Defective Device 7 7
Computer Operating System Problem 6 6
Measurement System Incompatibility 6 6
Loose or Intermittent Connection 6 6
Electrical /Electronic Property Problem 6 6
Communication or Transmission Problem 6 6
Unintended Electrical Shock 5 5
Failure to Charge 5 5
Break 5 5
Premature Discharge of Battery 5 5
Melted 5 5
Appropriate Term/Code Not Available 5 5
Material Deformation 4 4
Wireless Communication Problem 4 4
Circuit Failure 4 4
Device Fell 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 535 535
No Consequences Or Impact To Patient 159 159
No Known Impact Or Consequence To Patient 67 67
Insufficient Information 62 62
No Patient Involvement 19 19
Cardiac Arrest 8 8
Electric Shock 6 6
Death 5 5
No Information 3 3
Injury 3 3
Burn(s) 3 3
Superficial (First Degree) Burn 2 2
No Code Available 2 2
Discomfort 2 2
Laceration(s) 2 2
Unspecified Tissue Injury 2 2
Cyanosis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Non specific EKG/ECG Changes 1 1
Arrhythmia 1 1
Hypersensitivity/Allergic reaction 1 1
Seizures 1 1
Respiratory Arrest 1 1
Skin Disorders 1 1
Skin Discoloration 1 1
Loss Of Pulse 1 1
Ventricular Fibrillation 1 1
Nerve Damage 1 1
Erythema 1 1
Swelling 1 1
Cardiopulmonary Arrest 1 1
Valvular Stenosis 1 1
Asystole 1 1
Vascular System (Circulation), Impaired 1 1
Shock 1 1
Swelling/ Edema 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Heart Problem 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 MEDICAL SYSTEMS NEDERLAND B.V. II May-30-2024
5 Philips North America, LLC II Aug-14-2020
6 Philips North America, LLC II Jun-02-2020
7 Philips North America, LLC II Mar-31-2020
8 Philips North America Llc II Oct-04-2022
9 Philips North America Llc II May-06-2022
10 Philips North America Llc II Apr-29-2021
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