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TPLC
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Device
detector and alarm, arrhythmia
Product Code
DSI
Regulation Number
870.1025
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
999
999
2015
1639
1639
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
232
232
Device Problems
MDRs with this Device Problem
Events in those MDRs
Under-Sensing
7209
7209
Over-Sensing
4678
4678
Premature Discharge of Battery
3373
3373
No Audible Alarm
2979
2979
Signal Artifact/Noise
1543
1543
Device Sensing Problem
1440
1440
No Audible Prompt/Feedback
1336
1336
Migration or Expulsion of Device
1211
1211
Adverse Event Without Identified Device or Use Problem
822
822
Device Operates Differently Than Expected
693
693
Communication or Transmission Problem
673
673
Unable to Obtain Readings
669
669
Failure to Interrogate
633
633
Reset Problem
584
584
Invalid Sensing
506
506
Device Alarm System
460
460
No Device Output
408
408
Device Displays Incorrect Message
405
405
Electromagnetic Interference
402
402
Appropriate Term/Code Not Available
361
361
Battery Problem
352
352
Decreased Sensitivity
321
321
Inaudible or Unclear Audible Prompt/Feedback
244
244
Inappropriate or Unexpected Reset
180
180
Incorrect Measurement
152
152
Defective Alarm
130
130
Failure to Transmit Record
107
107
Output Problem
99
99
Defective Device
98
98
Device Inoperable
97
97
Mechanical Problem
92
92
Break
78
78
Data Problem
77
77
Insufficient Information
76
76
Component Missing
74
74
Defective Component
73
73
Positioning Problem
63
63
Device Difficult to Program or Calibrate
61
61
False Positive Result
58
58
No Display/Image
56
56
Display or Visual Feedback Problem
51
51
Nonstandard Device
47
47
Overheating of Device
46
46
Patient Device Interaction Problem
46
46
Audible Prompt/Feedback Problem
46
46
Alarm Not Visible
43
43
Use of Device Problem
40
40
Therapeutic or Diagnostic Output Failure
37
37
Protective Measures Problem
33
33
Incorrect, Inadequate or Imprecise Result or Readings
32
32
Patient-Device Incompatibility
32
32
Computer Operating System Problem
31
31
Device-Device Incompatibility
31
31
Low Audible Alarm
28
28
Loss of Power
27
27
Failure to Power Up
27
27
Temperature Problem
25
25
Excessive Heating
25
25
Noise, Audible
21
21
Electrical /Electronic Property Problem
21
21
Biocompatibility
19
19
Melted
18
18
Computer Software Problem
16
16
Human-Device Interface Problem
16
16
Difficult to Remove
16
16
Smoking
16
16
Failure to Sense
15
15
Detachment of Device or Device Component
14
14
Disconnection
14
14
Device Expiration Issue
13
13
Delayed Alarm
13
13
Device Maintenance Issue
13
13
Improper or Incorrect Procedure or Method
13
13
Wireless Communication Problem
13
13
Device Fell
13
13
No Apparent Adverse Event
13
13
Connection Problem
12
12
Loss of Data
12
12
Battery Impedance Issue
11
11
Fire
10
10
Circuit Failure
10
10
Component Falling
10
10
Application Interface Becomes Non-Functional Or Program Exits Abnormally
9
9
Thermal Decomposition of Device
9
9
Loose or Intermittent Connection
9
9
Device Stops Intermittently
9
9
Inappropriate Audible Prompt/Feedback
8
8
Device Dislodged or Dislocated
8
8
Labelling, Instructions for Use or Training Problem
8
8
Material Integrity Problem
8
8
Mechanics Altered
8
8
Operating System Becomes Nonfunctional
7
7
Power Problem
7
7
Improper Device Output
7
7
Product Quality Problem
7
7
Self-Activation or Keying
7
7
Improper Flow or Infusion
6
6
Device Operational Issue
6
6
Pacing Problem
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
15395
15395
No Clinical Signs, Symptoms or Conditions
6327
6327
No Patient Involvement
1991
1991
No Consequences Or Impact To Patient
1579
1579
Unspecified Infection
426
426
Pain
362
362
Erosion
259
259
Insufficient Information
193
193
Death
134
134
No Code Available
111
111
Discomfort
110
110
Unspecified Heart Problem
101
101
Cardiac Arrest
73
73
Impaired Healing
72
72
Erythema
65
65
Hypersensitivity/Allergic reaction
54
54
Skin Irritation
46
46
Skin Inflammation/ Irritation
44
44
Bradycardia
30
30
Swelling
29
29
Chest Pain
29
29
Low Oxygen Saturation
28
28
Complaint, Ill-Defined
28
28
Purulent Discharge
27
27
Blister
26
26
Itching Sensation
26
26
No Information
25
25
Syncope
23
23
Burning Sensation
22
22
Dizziness
22
22
Wound Dehiscence
22
22
Rash
20
20
Arrhythmia
20
20
Ventricular Tachycardia
19
19
Blood Loss
19
19
Hematoma
18
18
Tachycardia
18
18
Twiddlers Syndrome
18
18
Dyspnea
16
16
Hypoxia
16
16
Burn(s)
15
15
Hemorrhage/Bleeding
14
14
Skin Erosion
14
14
Bruise/Contusion
13
13
Injury
13
13
Ventricular Fibrillation
12
12
Asystole
12
12
Cellulitis
11
11
Pocket Erosion
11
11
Bacterial Infection
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Loss of consciousness
11
11
Fall
11
11
Cardiopulmonary Arrest
10
10
Palpitations
10
10
Swelling/ Edema
9
9
Skin Tears
8
8
Low Blood Pressure/ Hypotension
7
7
Diaphoresis
7
7
Electric Shock
7
7
Atrial Fibrillation
7
7
Skin Discoloration
7
7
Superficial (First Degree) Burn
7
7
Seizures
7
7
Stroke/CVA
7
7
Twiddlers Syndrome
7
7
Shock
6
6
Burn, Thermal
6
6
Skin Inflammation
6
6
Irritation
5
5
Discharge
5
5
Tissue Breakdown
5
5
Chest Tightness/Pressure
4
4
Caustic/Chemical Burns
4
4
Failure of Implant
4
4
Unspecified Respiratory Problem
4
4
Cyanosis
4
4
Inflammation
4
4
Endocarditis
4
4
Unspecified Tissue Injury
4
4
Skin Infection
4
4
Fluid Discharge
4
4
Local Reaction
4
4
Pneumothorax
4
4
Loss Of Pulse
4
4
Fever
4
4
High Blood Pressure/ Hypertension
3
3
Increased Sensitivity
3
3
Shock from Patient Lead(s)
3
3
Sweating
3
3
Headache
3
3
Apnea
3
3
Syncope/Fainting
3
3
Patient Problem/Medical Problem
3
3
Tingling
3
3
Tissue Damage
3
3
Localized Skin Lesion
3
3
Skin Burning Sensation
3
3
Sudden Cardiac Death
3
3
Fatigue
3
3
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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