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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
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 5
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS (CHINA) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  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 2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 9
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
REMOTE DIAGNOSTIC TECHNOLOGIES LTD
  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 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 1470 1470
2023 2252 2252
2024 1831 1831

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1765 1765
Device Alarm System 1225 1225
Communication or Transmission Problem 1199 1199
Nonstandard Device 733 733
Output Problem 725 725
Patient Device Interaction Problem 679 679
No Audible Prompt/Feedback 662 662
Display or Visual Feedback Problem 649 649
Application Program Problem 607 607
Defective Alarm 559 559
Device Operates Differently Than Expected 532 532
No Display/Image 515 515
Computer Operating System Problem 456 456
Adverse Event Without Identified Device or Use Problem 443 443
Device Displays Incorrect Message 419 419
Power Problem 408 408
Unintended Application Program Shut Down 361 361
Protective Measures Problem 335 335
Inappropriate or Unexpected Reset 325 325
Unable to Obtain Readings 284 284
Unexpected Shutdown 253 253
Application Program Freezes, Becomes Nonfunctional 243 243
Incorrect, Inadequate or Imprecise Result or Readings 217 217
Wireless Communication Problem 215 215
No Device Output 193 193
Therapeutic or Diagnostic Output Failure 157 157
Computer Software Problem 152 152
Electrical /Electronic Property Problem 139 139
Alarm Not Visible 139 139
Defective Component 134 134
Device Inoperable 134 134
Failure to Power Up 126 126
Appropriate Term/Code Not Available 120 120
Insufficient Information 118 118
Application Interface Becomes Non-Functional Or Program Exits Abnormally 116 116
Complete Loss of Power 109 109
Reset Problem 106 106
Mechanical Problem 101 101
Inaudible or Unclear Audible Prompt/Feedback 99 99
Defective Device 99 99
Audible Prompt/Feedback Problem 98 98
Loss of Power 97 97
Break 95 95
Incorrect Measurement 95 95
Failure to Charge 94 94
Erratic or Intermittent Display 89 89
Intermittent Communication Failure 88 88
Patient Data Problem 83 83
Loose or Intermittent Connection 74 74
Data Problem 71 71

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7164 7164
No Known Impact Or Consequence To Patient 3270 3270
No Consequences Or Impact To Patient 1520 1520
Skin Inflammation/ Irritation 937 937
Insufficient Information 478 478
Death 409 409
No Patient Involvement 334 334
Cardiac Arrest 204 204
Low Oxygen Saturation 118 118
Injury 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
Asystole 46 46
No Information 46 46
Cardiopulmonary Arrest 42 42
No Code Available 41 41
Skin Irritation 41 41
Bradycardia 38 38
Tachycardia 36 36
Blister 35 35
Patient Problem/Medical Problem 34 34
Unspecified Heart Problem 28 28
Arrhythmia 27 27
Ventricular Tachycardia 26 26
Hypoxia 23 23
Ventricular Fibrillation 22 22
Itching Sensation 19 19
Erythema 15 15
Cyanosis 13 13
Bruise/Contusion 13 13
Burning Sensation 13 13
Burn(s) 13 13
Laceration(s) 13 13
Hemorrhage/Bleeding 13 13
Loss of consciousness 13 13
Loss Of Pulse 12 12
Fall 12 12
Low Blood Pressure/ Hypotension 12 12
High Blood Pressure/ Hypertension 11 11
Pressure Sores 10 10
Skin Burning Sensation 9 9
Apnea 9 9
Burn, Thermal 9 9
Head Injury 8 8
Abrasion 8 8
Skin Tears 7 7
Electric Shock 7 7
Respiratory Distress 7 7
Superficial (First Degree) Burn 6 6
Complaint, Ill-Defined 6 6
Respiratory Arrest 6 6

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 Draeger Medical Systems, Inc. II Jun-25-2024
13 Draeger Medical Systems, Inc. II Apr-27-2023
14 Edan Diagnostics II Feb-18-2020
15 Edan Diagnostics II Oct-11-2018
16 Fukuda Denshi Co., Ltd. II Dec-06-2017
17 GE Healthcare Finland Oy II Jun-21-2024
18 GE Healthcare, LLC II Jul-23-2021
19 GE Healthcare, LLC II Aug-04-2020
20 GE Healthcare, LLC II Jun-24-2020
21 GE Healthcare, LLC II Dec-07-2018
22 GE Healthcare, LLC II Nov-29-2018
23 GE Medical Systems China Co., Ltd. II Sep-29-2023
24 GE Medical Systems Information Technologies, Inc. II Dec-06-2017
25 GE Medical Systems, LLC II Dec-19-2022
26 Mindray DS USA, Inc. dba Mindray North America II Oct-17-2018
27 Mindray DS USA, Inc. dba Mindray North America II Jun-27-2017
28 Nihon Kohden America Inc II Jun-06-2024
29 Nihon Kohden America Inc II Mar-20-2017
30 Philips Electronics North America Corporation II Aug-22-2018
31 Philips Electronics North America Corporation II Apr-06-2018
32 Philips Electronics North America Corporation II Mar-03-2018
33 Philips Electronics North America Corporation II Feb-28-2018
34 Philips Electronics North America Corporation II Dec-27-2017
35 Philips Electronics North America Corporation III Dec-20-2017
36 Philips Electronics North America Corporation II Jun-13-2017
37 Philips Electronics North America Corporation II May-31-2017
38 Philips Electronics North America Corporation II Feb-22-2017
39 Philips North America, LLC II Mar-30-2021
40 Philips North America, LLC II Jul-23-2020
41 Philips North America, LLC II Jul-23-2020
42 Philips North America, LLC II Apr-23-2020
43 Philips North America, LLC II Sep-19-2019
44 Philips North America, LLC III Jun-12-2019
45 Philips North America, LLC II May-13-2019
46 Philips North America, LLC II Mar-28-2019
47 Philips North America II Mar-27-2024
48 Philips North America II Jan-13-2024
49 Philips North America Llc II Aug-05-2024
50 Philips North America Llc II May-15-2024
51 Philips North America Llc II Apr-25-2024
52 Philips North America Llc II Sep-19-2023
53 Remote Diagnostic Technologies Ltd. II Sep-21-2023
54 Remote Diagnostic Technologies Ltd. II Apr-01-2023
55 Remote Diagnostic Technologies Ltd. II Jul-01-2021
56 Spacelabs Healthcare, Inc. II Aug-11-2022
57 Spacelabs Healthcare, Inc. II Jun-04-2020
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