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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
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
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN DIGITAL HEALTH SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 6
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  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 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 1497 1497
Communication or Transmission Problem 1117 1117
Device Alarm System 941 941
Patient Device Interaction Problem 678 678
Output Problem 665 665
No Audible Prompt/Feedback 652 652
Display or Visual Feedback Problem 589 589
Application Program Problem 564 564
Defective Alarm 483 483
Adverse Event Without Identified Device or Use Problem 392 392
Power Problem 378 378
Unintended Application Program Shut Down 331 331
Protective Measures Problem 313 313
No Display/Image 298 298
Unable to Obtain Readings 276 276
Unexpected Shutdown 231 231
Application Program Freezes, Becomes Nonfunctional 226 226
Wireless Communication Problem 192 192
Incorrect, Inadequate or Imprecise Result or Readings 176 176
Therapeutic or Diagnostic Output Failure 157 157
Computer Software Problem 136 136
Computer Operating System Problem 128 128
No Device Output 124 124
Electrical /Electronic Property Problem 118 118
Alarm Not Visible 115 115
Device Displays Incorrect Message 107 107
Failure to Power Up 104 104
Defective Component 102 102
Audible Prompt/Feedback Problem 98 98
Failure to Charge 93 93
Incorrect Measurement 88 88
Intermittent Communication Failure 87 87
Complete Loss of Power 87 87
Insufficient Information 86 86
Inaudible or Unclear Audible Prompt/Feedback 83 83
Erratic or Intermittent Display 81 81
Appropriate Term/Code Not Available 79 79
Mechanical Problem 78 78
Nonstandard Device 75 75
Break 73 73
Patient Data Problem 72 72
Loose or Intermittent Connection 70 70
Defective Device 66 66
Charging Problem 66 66
Device Fell 61 61
Data Problem 60 60
Use of Device Problem 52 52
Overheating of Device 49 49
Inappropriate or Unexpected Reset 46 46
Loss of Data 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7151 7151
No Known Impact Or Consequence To Patient 1302 1302
Skin Inflammation/ Irritation 937 937
No Consequences Or Impact To Patient 762 762
Insufficient Information 478 478
No Patient Involvement 216 216
Death 197 197
Cardiac Arrest 169 169
Low Oxygen Saturation 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
Asystole 46 46
Skin Irritation 41 41
Blister 35 35
Tachycardia 32 32
Cardiopulmonary Arrest 30 30
Unspecified Heart Problem 28 28
Bradycardia 27 27
Arrhythmia 26 26
Hypoxia 21 21
Itching Sensation 19 19
Patient Problem/Medical Problem 14 14
Ventricular Fibrillation 13 13
Erythema 13 13
Burning Sensation 11 11
Hemorrhage/Bleeding 11 11
Laceration(s) 11 11
Loss of consciousness 10 10
Skin Burning Sensation 9 9
Low Blood Pressure/ Hypotension 9 9
Injury 9 9
High Blood Pressure/ Hypertension 9 9
No Code Available 9 9
Burn(s) 8 8
Ventricular Tachycardia 8 8
Bruise/Contusion 7 7
Loss Of Pulse 7 7
Skin Tears 7 7
Fall 7 7
Respiratory Arrest 6 6
Apnea 6 6
Head Injury 5 5
Cyanosis 5 5
Unspecified Respiratory Problem 5 5
Superficial (First Degree) Burn 5 5
Localized Skin Lesion 5 5
Rash 4 4
Electric Shock 4 4
Unspecified Tissue Injury 4 4
Respiratory Failure 4 4
Shock 3 3

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 Draeger Medical Systems, Inc. II Jun-25-2024
8 Draeger Medical Systems, Inc. II Apr-27-2023
9 Edan Diagnostics II Feb-18-2020
10 GE Healthcare Finland Oy II Jun-21-2024
11 GE Healthcare, LLC II Jul-23-2021
12 GE Healthcare, LLC II Aug-04-2020
13 GE Healthcare, LLC II Jun-24-2020
14 GE Medical Systems China Co., Ltd. II Sep-29-2023
15 GE Medical Systems, LLC II Dec-19-2022
16 Nihon Kohden America Inc II Jun-06-2024
17 Philips North America, LLC II Mar-30-2021
18 Philips North America, LLC II Jul-23-2020
19 Philips North America, LLC II Jul-23-2020
20 Philips North America, LLC II Apr-23-2020
21 Philips North America, LLC II Sep-19-2019
22 Philips North America, LLC III Jun-12-2019
23 Philips North America, LLC II May-13-2019
24 Philips North America, LLC II Mar-28-2019
25 Philips North America II Mar-27-2024
26 Philips North America II Jan-13-2024
27 Philips North America Llc II Aug-05-2024
28 Philips North America Llc II May-15-2024
29 Philips North America Llc II Apr-25-2024
30 Philips North America Llc II Sep-19-2023
31 Remote Diagnostic Technologies Ltd. II Sep-21-2023
32 Remote Diagnostic Technologies Ltd. II Apr-01-2023
33 Remote Diagnostic Technologies Ltd. II Jul-01-2021
34 Spacelabs Healthcare, Inc. II Aug-11-2022
35 Spacelabs Healthcare, Inc. II Jun-04-2020
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