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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(with arrhythmia detection or alarms)
Product CodeMHX
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED INSTUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 6
GE MEDICAL SYSTEMS (CHINA) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTH-VISION TECH. INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 6
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
SOTERA WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1115 1115
2018 2157 2157
2019 1463 1463
2020 1714 1714
2021 2421 2421
2022 1340 1340

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1150 1150
Communication or Transmission Problem 1052 1052
Device Alarm System 1051 1051
Nonstandard Device 733 733
Output Problem 598 598
Device Operates Differently Than Expected 532 532
Application Program Problem 491 491
Computer Operating System Problem 447 447
Display or Visual Feedback Problem 446 446
Device Displays Incorrect Message 411 411
No Display/Image 409 409
No Audible Prompt/Feedback 376 376
Defective Alarm 368 368
Adverse Event Without Identified Device or Use Problem 360 360
Power Problem 335 335
Inappropriate or Unexpected Reset 315 315
Protective Measures Problem 278 278
Unintended Application Program Shut Down 270 270
Therapeutic or Diagnostic Output Failure 155 155
No Device Output 153 153
Incorrect, Inadequate or Imprecise Result or Readings 148 148
Application Program Freezes, Becomes Nonfunctional 134 134
Device Inoperable 134 134
Defective Component 132 132
Application Interface Becomes Non-Functional Or Program Exits Abnormally 116 116
Alarm Not Visible 108 108
Wireless Communication Problem 107 107
Appropriate Term/Code Not Available 102 102
Computer Software Problem 101 101
Reset Problem 101 101
Defective Device 96 96
Electrical /Electronic Property Problem 94 94
Unexpected Shutdown 94 94
Loss of Power 94 94
Inaudible or Unclear Audible Prompt/Feedback 90 90
Insufficient Information 82 82
Complete Loss of Power 77 77
Audible Prompt/Feedback Problem 72 72
Break 70 70
Mechanical Problem 68 68
Device Fell 59 59
Patient Data Problem 59 59
Failure to Power Up 56 56
Device Issue 56 56
Overheating of Device 56 56
Intermittent Communication Failure 56 56
Device Stops Intermittently 52 52
Device Operational Issue 51 51
Incorrect Measurement 50 50
Data Problem 49 49
Loss of Data 48 48
Unable to Obtain Readings 48 48
Use of Device Problem 43 43
Connection Problem 40 40
Operating System Becomes Nonfunctional 40 40
Patient-Device Incompatibility 38 38
Device Sensing Problem 32 32
Low Readings 30 30
Failure to Discharge 30 30
Improper or Incorrect Procedure or Method 28 28
Detachment of Device or Device Component 27 27
Fire 26 26
Erratic or Intermittent Display 25 25
Loose or Intermittent Connection 23 23
Component Falling 23 23
Image Display Error/Artifact 23 23
Delayed Alarm 22 22
Disconnection 22 22
Thermal Decomposition of Device 22 22
Temperature Problem 21 21
Use of Incorrect Control/Treatment Settings 21 21
Noise, Audible 18 18
Self-Activation or Keying 18 18
Smoking 17 17
Intermittent Loss of Power 17 17
Improper Alarm 16 16
No Visual Prompts/Feedback 15 15
Application Network Problem 15 15
Failure to Sense 15 15
Failure to Read Input Signal 14 14
High Readings 14 14
Component Missing 13 13
Compatibility Problem 13 13
False Alarm 12 12
Telemetry Discrepancy 12 12
Inappropriate Audible Prompt/Feedback 12 12
Incorrect Interpretation of Signal 12 12
Melted 12 12
Human Factors Issue 11 11
Human-Device Interface Problem 11 11
Battery Problem 11 11
Electrical Power Problem 10 10
Invalid Sensing 10 10
Low Audible Alarm 9 9
Signal Artifact/Noise 9 9
Detachment Of Device Component 9 9
Pumping Problem 9 9
False Reading From Device Non-Compliance 9 9
Failure to Analyze Signal 8 8
Intermittent Continuity 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3815 3815
No Known Impact Or Consequence To Patient 3270 3270
No Consequences Or Impact To Patient 1520 1520
Death 409 409
Insufficient Information 337 337
No Patient Involvement 334 334
Skin Inflammation/ Irritation 223 223
Cardiac Arrest 119 119
Low Oxygen Saturation 95 95
Injury 55 55
No Information 46 46
Cardiopulmonary Arrest 42 42
Skin Irritation 41 41
No Code Available 41 41
Patient Problem/Medical Problem 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Ventricular Tachycardia 26 26
Bradycardia 25 25
Asystole 20 20
Arrhythmia 19 19
Ventricular Fibrillation 16 16
Blister 16 16
Tachycardia 14 14
Itching Sensation 14 14
Hypoxia 14 14
Loss of consciousness 13 13
Cyanosis 12 12
Fall 12 12
Loss Of Pulse 12 12
Erythema 11 11
Bruise/Contusion 11 11
Low Blood Pressure/ Hypotension 10 10
Pressure Sores 10 10
High Blood Pressure/ Hypertension 9 9
Burn, Thermal 9 9
Burning Sensation 8 8
Burn(s) 8 8
Abrasion 7 7
Hemorrhage/Bleeding 7 7
Electric Shock 7 7
Laceration(s) 7 7
Respiratory Distress 7 7
Complaint, Ill-Defined 6 6
Head Injury 5 5
Superficial (First Degree) Burn 5 5
Respiratory Arrest 5 5
Apnea 5 5
Skin Burning Sensation 5 5
Respiratory Failure 4 4
Skin Tears 4 4
Overdose 4 4
Unspecified Tissue Injury 4 4
Brain Injury 3 3
Myocardial Infarction 3 3
Unspecified Heart Problem 3 3
Hematoma 3 3
Sudden Cardiac Death 3 3
Atrial Fibrillation 3 3
Pain 3 3
Full thickness (Third Degree) Burn 3 3
Unspecified Kidney or Urinary Problem 2 2
Blood Loss 2 2
Vomiting 2 2
Dizziness 2 2
Distress 2 2
Seizures 2 2
Hemorrhage, Subarachnoid 2 2
Syncope 2 2
Anoxia 2 2
Unspecified Respiratory Problem 2 2
Irregular Pulse 2 2
Partial thickness (Second Degree) Burn 2 2
Shock from Patient Lead(s) 2 2
Non specific EKG/ECG Changes 2 2
Encephalopathy 2 2
Rash 2 2
Skin Discoloration 2 2
ST Segment Elevation 2 2
Dyspnea 2 2
Pallor 2 2
Swelling 2 2
Complete Heart Block 2 2
Tissue Damage 2 2
Heart Failure 2 2
Diminished Pulse Pressure 2 2
Localized Skin Lesion 2 2
Skin Disorders 1 1
Swelling/ Edema 1 1
Heart Block 1 1
Hallucination 1 1
Weight Changes 1 1
Vascular System (Circulation), Impaired 1 1
Increased Respiratory Rate 1 1
Confusion/ Disorientation 1 1
Urinary Retention 1 1
Jaundice 1 1
Pulmonary Edema 1 1
Nausea 1 1
Necrosis 1 1
Liver Damage/Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Datascope Corp. II Nov-01-2019
2 Draegar Medical Systems, Inc. II Apr-27-2022
3 Draegar Medical Systems, Inc. II Feb-10-2021
4 Draegar Medical Systems, Inc. II Nov-14-2019
5 Draegar Medical Systems, Inc. II Oct-31-2019
6 Draegar Medical Systems, Inc. II Mar-05-2019
7 Draegar Medical Systems, Inc. II May-14-2018
8 Draegar Medical Systems, Inc. II Apr-16-2018
9 Draegar Medical Systems, Inc. II Mar-09-2018
10 Draegar Medical Systems, Inc. II Jul-14-2017
11 Draegar Medical Systems, Inc. II Apr-10-2017
12 Edan Diagnostics II Feb-18-2020
13 Edan Diagnostics II Oct-11-2018
14 Fukuda Denshi Co., Ltd. II Dec-06-2017
15 GE Healthcare, LLC II Jul-23-2021
16 GE Healthcare, LLC II Aug-04-2020
17 GE Healthcare, LLC II Jun-24-2020
18 GE Healthcare, LLC II Dec-07-2018
19 GE Healthcare, LLC II Nov-29-2018
20 GE Medical Systems Information Technologies, Inc. II Dec-06-2017
21 Mindray DS USA, Inc. dba Mindray North America II Oct-17-2018
22 Mindray DS USA, Inc. dba Mindray North America II Jun-27-2017
23 Nihon Kohden America Inc II Mar-20-2017
24 Philips Electronics North America Corporation II Aug-22-2018
25 Philips Electronics North America Corporation II Apr-06-2018
26 Philips Electronics North America Corporation II Mar-03-2018
27 Philips Electronics North America Corporation II Feb-28-2018
28 Philips Electronics North America Corporation II Dec-27-2017
29 Philips Electronics North America Corporation III Dec-20-2017
30 Philips Electronics North America Corporation II Jun-13-2017
31 Philips Electronics North America Corporation II May-31-2017
32 Philips Electronics North America Corporation II Feb-22-2017
33 Philips North America, LLC II Mar-30-2021
34 Philips North America, LLC II Jul-23-2020
35 Philips North America, LLC II Jul-23-2020
36 Philips North America, LLC II Apr-23-2020
37 Philips North America, LLC II Sep-19-2019
38 Philips North America, LLC III Jun-12-2019
39 Philips North America, LLC II May-13-2019
40 Philips North America, LLC II Mar-28-2019
41 Remote Diagnostic Technologies Ltd. II Jul-01-2021
42 Spacelabs Healthcare, Inc. II Aug-11-2022
43 Spacelabs Healthcare, Inc. II Jun-04-2020
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