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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device monitor, physiological, patient(with arrhythmia detection or alarms)
Product CodeMHX
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAF MEDICAL SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
EDAN INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 8
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 1462 1462
2020 1714 1714
2021 2423 2423
2022 1470 1470
2023 2252 2252
2024 2292 2294

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1712 1712
Communication or Transmission Problem 1165 1165
Device Alarm System 1107 1107
Patient Device Interaction Problem 748 748
Nonstandard Device 733 733
Output Problem 730 730
No Audible Prompt/Feedback 685 685
Display or Visual Feedback Problem 658 658
Application Program Problem 606 606
Defective Alarm 573 573
Computer Operating System Problem 444 444
No Display/Image 422 422
Adverse Event Without Identified Device or Use Problem 414 414
Power Problem 400 400
Unintended Application Program Shut Down 362 362
Device Operates Differently Than Expected 348 348
Protective Measures Problem 336 336
Inappropriate or Unexpected Reset 322 322
Unable to Obtain Readings 316 316
Unexpected Shutdown 271 271
Device Displays Incorrect Message 267 267
Application Program Freezes, Becomes Nonfunctional 259 259
Incorrect, Inadequate or Imprecise Result or Readings 219 219
Wireless Communication Problem 215 215
No Device Output 181 183
Therapeutic or Diagnostic Output Failure 158 158
Computer Software Problem 154 154
Electrical /Electronic Property Problem 138 138
Alarm Not Visible 135 135
Defective Component 123 123
Failure to Power Up 115 115
Appropriate Term/Code Not Available 113 113
Failure to Charge 108 108
Insufficient Information 108 108
Complete Loss of Power 107 107
Reset Problem 104 104
Incorrect Measurement 99 99
Audible Prompt/Feedback Problem 98 98
Intermittent Communication Failure 96 96
Erratic or Intermittent Display 95 95
Inaudible or Unclear Audible Prompt/Feedback 94 94
Defective Device 94 94
Mechanical Problem 92 92
Break 88 88
Patient Data Problem 83 83
Application Interface Becomes Non-Functional Or Program Exits Abnormally 81 81
Loose or Intermittent Connection 75 75
Charging Problem 72 72
Device Fell 68 68
Data Problem 67 67

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7509 7509
No Known Impact Or Consequence To Patient 2584 2584
No Consequences Or Impact To Patient 1356 1356
Skin Inflammation/ Irritation 1006 1006
Insufficient Information 515 517
Death 296 296
No Patient Involvement 281 281
Cardiac Arrest 194 194
Low Oxygen Saturation 104 104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
Asystole 46 46
Skin Irritation 41 41
Tachycardia 35 35
Cardiopulmonary Arrest 35 35
Blister 35 35
Patient Problem/Medical Problem 34 34
Injury 33 33
Bradycardia 33 33
Unspecified Heart Problem 31 31
Arrhythmia 26 26
Hypoxia 22 22
No Information 20 20
No Code Available 20 20
Ventricular Fibrillation 19 19
Itching Sensation 19 19
Erythema 15 15
Hemorrhage/Bleeding 13 13
Ventricular Tachycardia 13 13
Burning Sensation 12 12
Laceration(s) 12 12
Bruise/Contusion 11 11
Burn(s) 11 11
Loss of consciousness 11 11
Low Blood Pressure/ Hypotension 11 11
Pressure Sores 10 10
Loss Of Pulse 10 10
Cyanosis 10 10
High Blood Pressure/ Hypertension 9 9
Skin Burning Sensation 9 9
Burn, Thermal 8 8
Fall 8 8
Apnea 8 8
Abrasion 8 8
Skin Tears 7 7
Superficial (First Degree) Burn 6 6
Respiratory Arrest 6 6
Electric Shock 6 6
Unspecified Respiratory Problem 5 5
Localized Skin Lesion 5 5
Head Injury 5 5

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 Jun-25-2024
11 Draeger Medical Systems, Inc. II Apr-27-2023
12 Edan Diagnostics II Feb-18-2020
13 Edan Diagnostics II Oct-11-2018
14 GE Healthcare Finland Oy II Jun-21-2024
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 China Co., Ltd. II Sep-29-2023
21 GE Medical Systems, LLC II Dec-19-2022
22 Mindray DS USA, Inc. dba Mindray North America II Oct-17-2018
23 Nihon Kohden America Inc II Jun-06-2024
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 North America, LLC II Mar-30-2021
29 Philips North America, LLC II Jul-23-2020
30 Philips North America, LLC II Jul-23-2020
31 Philips North America, LLC II Apr-23-2020
32 Philips North America, LLC II Sep-19-2019
33 Philips North America, LLC III Jun-12-2019
34 Philips North America, LLC II May-13-2019
35 Philips North America, LLC II Mar-28-2019
36 Philips North America II Sep-25-2024
37 Philips North America II Mar-27-2024
38 Philips North America II Jan-13-2024
39 Philips North America Llc II Oct-04-2024
40 Philips North America Llc II Sep-30-2024
41 Philips North America Llc II Aug-05-2024
42 Philips North America Llc II May-15-2024
43 Philips North America Llc II Apr-25-2024
44 Philips North America Llc II Sep-19-2023
45 Remote Diagnostic Technologies Ltd. II Sep-21-2023
46 Remote Diagnostic Technologies Ltd. II Apr-01-2023
47 Remote Diagnostic Technologies Ltd. II Jul-01-2021
48 Spacelabs Healthcare, Inc. II Aug-11-2022
49 Spacelabs Healthcare, Inc. II Jun-04-2020
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