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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
1. K152305
Nihon Kohden Afib Detection Program QP-039P
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
524
524
Device Problems
MDRs with this Device Problem
Events in those MDRs
Under-Sensing
7266
7266
Over-Sensing
4751
4751
Premature Discharge of Battery
3373
3373
No Audible Alarm
3054
3054
Signal Artifact/Noise
1562
1562
Device Sensing Problem
1442
1442
No Audible Prompt/Feedback
1358
1358
Migration or Expulsion of Device
1215
1215
Adverse Event Without Identified Device or Use Problem
830
830
Device Operates Differently Than Expected
694
694
Communication or Transmission Problem
691
691
Unable to Obtain Readings
672
672
Failure to Interrogate
634
634
Reset Problem
595
595
Invalid Sensing
506
506
Device Alarm System
470
470
No Device Output
408
408
Electromagnetic Interference
405
405
Device Displays Incorrect Message
405
405
Appropriate Term/Code Not Available
365
365
Battery Problem
355
355
Decreased Sensitivity
323
323
Inaudible or Unclear Audible Prompt/Feedback
245
245
Inappropriate or Unexpected Reset
180
180
Incorrect Measurement
152
152
Defective Alarm
136
136
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
62
62
False Positive Result
58
58
No Display/Image
56
56
Overheating of Device
52
52
Display or Visual Feedback Problem
51
51
Audible Prompt/Feedback Problem
49
49
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
35
35
Incorrect, Inadequate or Imprecise Result or Readings
33
33
Patient-Device Incompatibility
32
32
Computer Operating System Problem
31
31
Device-Device Incompatibility
31
31
Low Audible Alarm
30
30
Loss of Power
27
27
Failure to Power Up
27
27
Temperature Problem
25
25
Excessive Heating
25
25
Electrical /Electronic Property Problem
23
23
Biocompatibility
22
22
Noise, Audible
22
22
Melted
20
20
Smoking
18
18
Difficult to Remove
16
16
Human-Device Interface Problem
16
16
Computer Software Problem
16
16
Delayed Alarm
16
16
Disconnection
15
15
Failure to Sense
15
15
Detachment of Device or Device Component
14
14
Connection Problem
13
13
Improper or Incorrect Procedure or Method
13
13
Device Expiration Issue
13
13
Device Maintenance Issue
13
13
Wireless Communication Problem
13
13
No Apparent Adverse Event
13
13
Device Fell
13
13
Loss of Data
12
12
Battery Impedance Issue
11
11
Fire
10
10
Component Falling
10
10
Circuit Failure
10
10
Thermal Decomposition of Device
9
9
Application Interface Becomes Non-Functional Or Program Exits Abnormally
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
Operating System Becomes Nonfunctional
8
8
Material Integrity Problem
8
8
Mechanics Altered
8
8
Power Problem
7
7
Improper Device Output
7
7
Self-Activation or Keying
7
7
Product Quality Problem
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
15397
15397
No Clinical Signs, Symptoms or Conditions
6606
6606
No Patient Involvement
1991
1991
No Consequences Or Impact To Patient
1579
1579
Unspecified Infection
430
430
Pain
367
367
Erosion
260
260
Insufficient Information
197
197
Death
134
134
Discomfort
114
114
No Code Available
111
111
Unspecified Heart Problem
101
101
Cardiac Arrest
74
74
Impaired Healing
72
72
Erythema
68
68
Hypersensitivity/Allergic reaction
54
54
Skin Irritation
46
46
Skin Inflammation/ Irritation
46
46
Bradycardia
30
30
Purulent Discharge
29
29
Chest Pain
29
29
Swelling
29
29
Complaint, Ill-Defined
28
28
Low Oxygen Saturation
28
28
Itching Sensation
27
27
Blister
26
26
No Information
25
25
Wound Dehiscence
23
23
Syncope
23
23
Burning Sensation
23
23
Dizziness
22
22
Arrhythmia
21
21
Rash
21
21
Ventricular Tachycardia
19
19
Blood Loss
19
19
Twiddlers Syndrome
18
18
Tachycardia
18
18
Hematoma
18
18
Hemorrhage/Bleeding
17
17
Hypoxia
16
16
Dyspnea
16
16
Burn(s)
15
15
Skin Erosion
14
14
Ventricular Fibrillation
13
13
Injury
13
13
Bruise/Contusion
13
13
Asystole
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Swelling/ Edema
11
11
Bacterial Infection
11
11
Cellulitis
11
11
Fall
11
11
Pocket Erosion
11
11
Loss of consciousness
11
11
Palpitations
10
10
Electric Shock
10
10
Cardiopulmonary Arrest
10
10
Superficial (First Degree) Burn
9
9
Skin Tears
8
8
Diaphoresis
7
7
Skin Discoloration
7
7
Atrial Fibrillation
7
7
Stroke/CVA
7
7
Seizures
7
7
Low Blood Pressure/ Hypotension
7
7
Twiddlers Syndrome
7
7
Shock
6
6
Skin Inflammation
6
6
Burn, Thermal
6
6
Discharge
5
5
Local Reaction
5
5
Irritation
5
5
Tissue Breakdown
5
5
Fluid Discharge
4
4
Shock from Patient Lead(s)
4
4
Unspecified Respiratory Problem
4
4
Skin Infection
4
4
Unspecified Tissue Injury
4
4
Perforation
4
4
Endocarditis
4
4
Headache
4
4
Failure of Implant
4
4
Inflammation
4
4
Cyanosis
4
4
Fever
4
4
Pneumothorax
4
4
Caustic/Chemical Burns
4
4
Loss Of Pulse
4
4
Chest Tightness/Pressure
4
4
Respiratory Failure
3
3
Sudden Cardiac Death
3
3
Sweating
3
3
Reaction
3
3
Scar Tissue
3
3
Tissue Damage
3
3
Tingling
3
3
Fatigue
3
3
Apnea
3
3
High Blood Pressure/ Hypertension
3
3
Increased Sensitivity
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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