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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
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORTH-VISION TECH. INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 6
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
SOTERA WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2157 2157
2019 1463 1463
2020 1714 1714
2021 2421 2421
2022 1465 1465
2023 1327 1327

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1263 1263
Communication or Transmission Problem 1067 1067
Device Alarm System 996 996
Nonstandard Device 733 733
Output Problem 654 654
Application Program Problem 554 554
Display or Visual Feedback Problem 529 529
No Audible Prompt/Feedback 485 485
Computer Operating System Problem 438 438
Defective Alarm 397 397
Adverse Event Without Identified Device or Use Problem 396 396
Power Problem 378 378
Device Operates Differently Than Expected 348 348
No Display/Image 343 343
Inappropriate or Unexpected Reset 317 317
Unintended Application Program Shut Down 316 316
Protective Measures Problem 304 304
Device Displays Incorrect Message 264 264
Incorrect, Inadequate or Imprecise Result or Readings 170 170
Application Program Freezes, Becomes Nonfunctional 168 168
Therapeutic or Diagnostic Output Failure 157 157
No Device Output 146 146
Patient Device Interaction Problem 140 140
Unexpected Shutdown 140 140
Computer Software Problem 123 123
Defective Component 123 123
Wireless Communication Problem 118 118
Unable to Obtain Readings 116 116
Alarm Not Visible 116 116
Appropriate Term/Code Not Available 109 109
Electrical /Electronic Property Problem 107 107
Reset Problem 101 101
Complete Loss of Power 96 96
Defective Device 94 94
Audible Prompt/Feedback Problem 88 88
Inaudible or Unclear Audible Prompt/Feedback 86 86
Application Interface Becomes Non-Functional Or Program Exits Abnormally 81 81
Insufficient Information 79 79
Intermittent Communication Failure 70 70
Patient Data Problem 68 68
Incorrect Measurement 67 67
Break 63 63
Mechanical Problem 62 62
Device Fell 62 62
Loose or Intermittent Connection 61 61
Loss of Power 60 60
Failure to Power Up 58 58
Data Problem 56 56
Overheating of Device 49 49
Device Issue 49 49
Use of Device Problem 48 48
Loss of Data 47 47
Device Sensing Problem 46 46
Device Inoperable 44 44
Patient-Device Incompatibility 39 39
Operating System Becomes Nonfunctional 39 39
Connection Problem 38 38
Device Operational Issue 34 34
Low Readings 34 34
Erratic or Intermittent Display 33 33
Failure to Discharge 30 30
Detachment of Device or Device Component 30 30
Failure to Analyze Signal 28 28
Application Network Problem 26 26
Fire 26 26
Signal Artifact/Noise 25 25
Intermittent Loss of Power 25 25
Use of Incorrect Control/Treatment Settings 23 23
Disconnection 22 22
Device Stops Intermittently 22 22
No Visual Prompts/Feedback 22 22
Delayed Alarm 21 21
Image Display Error/Artifact 20 20
Improper or Incorrect Procedure or Method 20 20
High Readings 18 18
Failure to Charge 18 18
Failure to Sense 16 16
Thermal Decomposition of Device 15 15
Smoking 14 14
Battery Problem 14 14
Device Handling Problem 14 14
Human-Device Interface Problem 14 14
Temperature Problem 14 14
Compatibility Problem 13 13
Inappropriate Audible Prompt/Feedback 13 13
Self-Activation or Keying 12 12
False Alarm 12 12
Noise, Audible 12 12
Failure of Device to Self-Test 11 11
Low Audible Alarm 11 11
Failure to Read Input Signal 11 11
Component Missing 11 11
Incorrect Interpretation of Signal 10 10
Electrical Power Problem 10 10
Human Factors Issue 9 9
Pumping Problem 9 9
Failure to Calibrate 9 9
Calibration Problem 9 9
Display Difficult to Read 8 8
Crack 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5104 5104
No Known Impact Or Consequence To Patient 2584 2584
No Consequences Or Impact To Patient 1357 1357
Skin Inflammation/ Irritation 401 401
Insufficient Information 387 387
Death 296 296
No Patient Involvement 281 281
Cardiac Arrest 157 157
Low Oxygen Saturation 87 87
Skin Irritation 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Cardiopulmonary Arrest 35 35
Patient Problem/Medical Problem 34 34
Asystole 34 34
Blister 34 34
Injury 33 33
Bradycardia 22 22
Hypoxia 22 22
Arrhythmia 21 21
No Information 20 20
No Code Available 20 20
Itching Sensation 19 19
Tachycardia 16 16
Ventricular Fibrillation 15 15
Erythema 14 14
Hemorrhage/Bleeding 13 13
Ventricular Tachycardia 13 13
Unspecified Heart Problem 13 13
Loss of consciousness 11 11
Burning Sensation 11 11
Pressure Sores 10 10
Low Blood Pressure/ Hypotension 10 10
Bruise/Contusion 10 10
Loss Of Pulse 10 10
High Blood Pressure/ Hypertension 9 9
Cyanosis 9 9
Fall 8 8
Laceration(s) 8 8
Burn(s) 8 8
Apnea 8 8
Burn, Thermal 8 8
Skin Tears 7 7
Skin Burning Sensation 7 7
Abrasion 7 7
Electric Shock 6 6
Superficial (First Degree) Burn 6 6
Localized Skin Lesion 5 5
Respiratory Arrest 5 5
Unspecified Tissue Injury 4 4
Complaint, Ill-Defined 4 4
Respiratory Failure 4 4
Rash 4 4
Respiratory Distress 3 3
Skin Discoloration 3 3
Brain Injury 3 3
Hematoma 3 3
Head Injury 3 3
Sudden Cardiac Death 3 3
Diminished Pulse Pressure 3 3
Unspecified Respiratory Problem 3 3
Unspecified Kidney or Urinary Problem 2 2
Swelling/ Edema 2 2
Blood Loss 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Pallor 2 2
Irregular Pulse 2 2
Encephalopathy 2 2
Hemorrhage, Subarachnoid 2 2
Anoxia 2 2
Atrial Fibrillation 2 2
Chest Pain 2 2
Dyspnea 2 2
Non specific EKG/ECG Changes 2 2
Heart Failure 2 2
Dizziness 2 2
Discomfort 2 2
Vomiting 2 2
Tissue Damage 2 2
ST Segment Elevation 2 2
Myocardial Infarction 2 2
Overdose 2 2
Pain 2 2
Peeling 1 1
Pulmonary Edema 1 1
Nausea 1 1
Nerve Damage 1 1
Failure of Implant 1 1
Seizures 1 1
Septic Shock 1 1
Skull Fracture 1 1
Swelling 1 1
Torsades-de-Pointes 1 1
Urinary Retention 1 1
Therapeutic Effects, Unexpected 1 1
Jaundice 1 1
Physical Entrapment 1 1
Distress 1 1
Anaphylactoid 1 1
Viral Infection 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 Draeger Medical Systems, Inc. II Apr-27-2023
11 Edan Diagnostics II Feb-18-2020
12 Edan Diagnostics II Oct-11-2018
13 GE Healthcare, LLC II Jul-23-2021
14 GE Healthcare, LLC II Aug-04-2020
15 GE Healthcare, LLC II Jun-24-2020
16 GE Healthcare, LLC II Dec-07-2018
17 GE Healthcare, LLC II Nov-29-2018
18 GE Medical Systems, LLC II Dec-19-2022
19 Mindray DS USA, Inc. dba Mindray North America II Oct-17-2018
20 Philips Electronics North America Corporation II Aug-22-2018
21 Philips Electronics North America Corporation II Apr-06-2018
22 Philips Electronics North America Corporation II Mar-03-2018
23 Philips Electronics North America Corporation II Feb-28-2018
24 Philips North America, LLC II Mar-30-2021
25 Philips North America, LLC II Jul-23-2020
26 Philips North America, LLC II Jul-23-2020
27 Philips North America, LLC II Apr-23-2020
28 Philips North America, LLC II Sep-19-2019
29 Philips North America, LLC III Jun-12-2019
30 Philips North America, LLC II May-13-2019
31 Philips North America, LLC II Mar-28-2019
32 Philips North America Llc II Sep-19-2023
33 Remote Diagnostic Technologies Ltd. II Sep-21-2023
34 Remote Diagnostic Technologies Ltd. II Apr-01-2023
35 Remote Diagnostic Technologies Ltd. II Jul-01-2021
36 Spacelabs Healthcare, Inc. II Aug-11-2022
37 Spacelabs Healthcare, Inc. II Jun-04-2020
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