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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device detector and alarm, arrhythmia
Product CodeDSI
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
BRAEMAR MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORCAM TECHNOLOGIA, SA
  SUBSTANTIALLY EQUIVALENT 1
CORVENTIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBAL INSTRUMENTATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
INFOBIONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTELESENS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
INTRICON DATRIX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIFEWATCH TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
LIFEWATCH TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL.GORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDICALGORITHMICS SP Z.O.O.
  SUBSTANTIALLY EQUIVALENT 1
MEDICOMP, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEMTEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
NATIONAL CARDIAC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
  SUBSTANTIALLY EQUIVALENT 2
PREVENTICE
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROSS MEDICAL TECHNOLOGY, INC
  SUBSTANTIALLY EQUIVALENT 1
SCOTTCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SMARTCARDIA SA
  SUBSTANTIALLY EQUIVALENT 1
SPACELABS HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITASYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WPR MEDICAL AS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1001 1001
2015 1641 1641
2016 4351 4351
2017 3594 3594
2018 3647 3647
2019 3483 3483
2020 3084 3084
2021 3092 3092
2022 1638 1638
2023 1669 1669
2024 952 952

Device Problems MDRs with this Device Problem Events in those MDRs
Under-Sensing 7316 7316
Over-Sensing 4792 4792
Premature Discharge of Battery 3374 3374
No Audible Alarm 3200 3200
Signal Artifact/Noise 1579 1579
Device Sensing Problem 1454 1454
No Audible Prompt/Feedback 1401 1401
Migration or Expulsion of Device 1220 1220
Adverse Event Without Identified Device or Use Problem 846 846
Communication or Transmission Problem 737 737
Device Operates Differently Than Expected 694 694
Unable to Obtain Readings 681 681
Failure to Interrogate 636 636
Reset Problem 610 610
Invalid Sensing 506 506
Device Alarm System 480 480
Electromagnetic Interference 409 409
No Device Output 408 408
Device Displays Incorrect Message 405 405
Appropriate Term/Code Not Available 369 369
Battery Problem 361 361
Decreased Sensitivity 323 323
Inaudible or Unclear Audible Prompt/Feedback 245 245
Inappropriate or Unexpected Reset 181 181
Defective Alarm 158 158
Incorrect Measurement 153 153
Failure to Transmit Record 107 107
Output Problem 101 101
Defective Device 98 98
Device Inoperable 97 97
Mechanical Problem 93 93
Data Problem 79 79
Break 78 78
Insufficient Information 76 76
Component Missing 74 74
Defective Component 73 73
Overheating of Device 67 67
Positioning Problem 63 63
Device Difficult to Program or Calibrate 62 62
False Positive Result 58 58
No Display/Image 56 56
Display or Visual Feedback Problem 52 52
Audible Prompt/Feedback Problem 50 50
Nonstandard Device 47 47
Patient Device Interaction Problem 46 46
Alarm Not Visible 43 43
Use of Device Problem 40 40
Therapeutic or Diagnostic Output Failure 37 37
Protective Measures Problem 36 36
Melted 34 34

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15397 15397
No Clinical Signs, Symptoms or Conditions 6992 6992
No Patient Involvement 1991 1991
No Consequences Or Impact To Patient 1579 1579
Unspecified Infection 437 437
Pain 369 369
Erosion 262 262
Insufficient Information 202 202
Death 134 134
Discomfort 114 114
No Code Available 111 111
Unspecified Heart Problem 101 101
Cardiac Arrest 79 79
Impaired Healing 72 72
Erythema 68 68
Skin Inflammation/ Irritation 54 54
Hypersensitivity/Allergic reaction 54 54
Skin Irritation 46 46
Bradycardia 31 31
Purulent Discharge 30 30
Swelling 29 29
Chest Pain 29 29
Itching Sensation 28 28
Complaint, Ill-Defined 28 28
Low Oxygen Saturation 28 28
Blister 27 27
No Information 25 25
Wound Dehiscence 23 23
Syncope 23 23
Burning Sensation 23 23
Dizziness 22 22
Tachycardia 22 22
Rash 22 22
Arrhythmia 21 21
Ventricular Tachycardia 19 19
Blood Loss 19 19
Twiddlers Syndrome 18 18
Hemorrhage/Bleeding 18 18
Hematoma 18 18
Hypoxia 16 16
Dyspnea 16 16
Asystole 15 15
Burn(s) 15 15
Skin Erosion 14 14
Ventricular Fibrillation 14 14
Superficial (First Degree) Burn 14 14
Bruise/Contusion 13 13
Injury 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Bacterial Infection 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Brentwood Medical Technology Corp II Jul-14-2011
2 GE Healthcare II Jan-05-2009
3 GE Healthcare, LLC II Dec-20-2019
4 GE Healthcare, LLC II Oct-23-2019
5 GE Medical Systems Information Tecnology II Sep-04-2009
6 GE Medical Systems Information Tecnology II May-04-2009
7 Medtronic Inc. II Mar-25-2016
8 Philips Electronics North America Corporation II Dec-10-2018
9 Philips Electronics North America Corporation II Jun-11-2018
10 Philips Electronics North America Corporation II Apr-04-2017
11 Philips Healthcare Inc. II Sep-29-2010
12 Philips Medical Systems II Jan-13-2009
13 Philips Medical Systems North America Co. Phillips II Oct-08-2010
14 Philips North America, LLC II Jul-10-2020
15 Philips North America, LLC II Jun-01-2019
16 Philips North America Llc II May-21-2021
17 Philips North America Llc II Dec-08-2020
18 Preventice Services, LLC II Jul-01-2020
19 Scottcare Corporation II Apr-01-2016
20 Scottcare Corporation II Apr-13-2012
21 Spacelabs Healthcare Inc II Aug-04-2016
22 Spacelabs Healthcare Inc II May-04-2015
23 Spacelabs Healthcare Inc II Apr-28-2015
24 Spacelabs Healthcare Inc II Jun-03-2014
25 Spacelabs Healthcare, Inc. II May-03-2023
26 Spacelabs Healthcare, Llc II Sep-14-2012
27 Spacelabs Healthcare, Llc II Jan-17-2012
28 Spacelabs Healthcare, Llc II Jan-11-2012
29 Welch Allyn Protocol, Inc II Aug-03-2011
30 Welch Allyn Protocol, Inc II Nov-12-2010
31 iRhythm Technologies, Inc. II Nov-04-2022
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