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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)
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
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 1
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 MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 5
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER AG
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2020 1714 1714
2021 2423 2423
2022 1470 1470
2023 2255 2255
2024 2816 2818
2025 227 227

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 1548 1548
Communication or Transmission Problem 961 961
Patient Device Interaction Problem 851 851
Device Alarm System 773 773
No Audible Prompt/Feedback 701 701
Output Problem 633 633
Display or Visual Feedback Problem 549 549
Application Program Problem 528 528
Defective Alarm 525 525
Adverse Event Without Identified Device or Use Problem 364 364
Unable to Obtain Readings 353 353
Power Problem 341 341
Unintended Application Program Shut Down 304 304
No Display/Image 286 286
Unexpected Shutdown 277 277
Protective Measures Problem 274 274
Application Program Freezes, Becomes Nonfunctional 259 259
Wireless Communication Problem 204 204
Incorrect, Inadequate or Imprecise Result or Readings 161 161
Computer Software Problem 133 133
Failure to Charge 133 133
Therapeutic or Diagnostic Output Failure 122 122
Electrical /Electronic Property Problem 111 111
Failure to Power Up 105 105
Intermittent Communication Failure 103 103
Erratic or Intermittent Display 100 100
Alarm Not Visible 98 98
Incorrect Measurement 98 98
Audible Prompt/Feedback Problem 98 98
Insufficient Information 96 96
No Device Output 85 87
Break 82 82
Complete Loss of Power 79 79
Charging Problem 76 76
Mechanical Problem 74 74
Inaudible or Unclear Audible Prompt/Feedback 70 70
Device Displays Incorrect Message 70 70
Patient Data Problem 69 69
Loose or Intermittent Connection 66 66
Data Problem 59 59
Defective Component 56 56
Appropriate Term/Code Not Available 54 54
Operating System Becomes Nonfunctional 53 53
Low Readings 51 51
Use of Device Problem 48 48
Delayed Alarm 45 45
Device Fell 45 45
Connection Problem 43 43
Computer Operating System Problem 43 43
Loss of Data 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7961 7963
Skin Inflammation/ Irritation 1115 1115
No Known Impact Or Consequence To Patient 597 597
Insufficient Information 560 562
No Consequences Or Impact To Patient 278 278
Cardiac Arrest 172 172
No Patient Involvement 117 117
Death 107 107
Low Oxygen Saturation 66 66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 55 55
Asystole 47 47
Blister 36 36
Skin Irritation 36 36
Unspecified Heart Problem 33 33
Tachycardia 33 33
Bradycardia 26 26
Arrhythmia 24 24
Hypoxia 19 19
Itching Sensation 19 19
Cardiopulmonary Arrest 17 17
Erythema 14 14
Ventricular Fibrillation 13 13
Burning Sensation 11 11
Hemorrhage/Bleeding 11 11
Laceration(s) 10 10
Skin Burning Sensation 9 9
High Blood Pressure/ Hypertension 8 8
Skin Tears 7 7
Apnea 7 7
Burn(s) 6 6
Bruise/Contusion 6 6
Fall 6 6
Low Blood Pressure/ Hypotension 6 6
Respiratory Arrest 6 6
Head Injury 5 5
Unspecified Respiratory Problem 5 5
Localized Skin Lesion 5 5
Superficial (First Degree) Burn 5 5
Rash 4 4
Hematoma 4 4
Loss of consciousness 4 4
Ventricular Tachycardia 4 4
Injury 4 4
Unspecified Tissue Injury 4 4
No Code Available 4 4
Swelling/ Edema 4 4
Patient Problem/Medical Problem 4 4
Electric Shock 3 3
Cyanosis 3 3
Chest Pain 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Draegar Medical Systems, Inc. II Apr-27-2022
2 Draegar Medical Systems, Inc. II Feb-10-2021
3 Draeger Medical Systems, Inc. II Jan-30-2025
4 Draeger Medical Systems, Inc. II Jun-25-2024
5 Draeger Medical Systems, Inc. II Apr-27-2023
6 Edan Diagnostics II Feb-18-2020
7 GE Healthcare Finland Oy II Jun-21-2024
8 GE Healthcare, LLC II Jul-23-2021
9 GE Healthcare, LLC II Aug-04-2020
10 GE Healthcare, LLC II Jun-24-2020
11 GE Medical Systems China Co., Ltd. II Sep-29-2023
12 GE Medical Systems, LLC II Dec-19-2022
13 Nihon Kohden America Inc II Jun-06-2024
14 Philips North America, LLC II Mar-30-2021
15 Philips North America, LLC II Jul-23-2020
16 Philips North America, LLC II Jul-23-2020
17 Philips North America, LLC II Apr-23-2020
18 Philips North America II Sep-25-2024
19 Philips North America II Mar-27-2024
20 Philips North America II Jan-13-2024
21 Philips North America Llc II Feb-05-2025
22 Philips North America Llc II Dec-17-2024
23 Philips North America Llc II Oct-04-2024
24 Philips North America Llc II Sep-30-2024
25 Philips North America Llc II Aug-05-2024
26 Philips North America Llc II May-15-2024
27 Philips North America Llc II Apr-25-2024
28 Philips North America Llc II Sep-19-2023
29 Remote Diagnostic Technologies Ltd. II Sep-21-2023
30 Remote Diagnostic Technologies Ltd. II Apr-01-2023
31 Remote Diagnostic Technologies Ltd. II Jul-01-2021
32 Spacelabs Healthcare, Inc. II Jan-07-2025
33 Spacelabs Healthcare, Inc. II Jan-07-2025
34 Spacelabs Healthcare, Inc. II Aug-11-2022
35 Spacelabs Healthcare, Inc. II Jun-04-2020
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