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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
INFOBIONIC, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDICALGORITHMICS S.A.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC
SUBSTANTIALLY EQUIVALENT
1
MEMTEC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NATIONAL CARDIAC, INC.
SUBSTANTIALLY EQUIVALENT
1
PREVENTICE TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
SMARTCARDIA SA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
3483
3483
2020
3084
3084
2021
3092
3092
2022
1638
1638
2023
1669
1669
2024
416
416
Device Problems
MDRs with this Device Problem
Events in those MDRs
Under-Sensing
3770
3770
Over-Sensing
2646
2646
No Audible Alarm
2020
2020
No Audible Prompt/Feedback
1136
1136
Signal Artifact/Noise
1113
1113
Device Sensing Problem
1078
1078
Communication or Transmission Problem
506
506
Adverse Event Without Identified Device or Use Problem
482
482
Reset Problem
444
444
Electromagnetic Interference
377
377
Migration or Expulsion of Device
377
377
Unable to Obtain Readings
363
363
Failure to Interrogate
262
262
Appropriate Term/Code Not Available
183
183
Device Alarm System
165
165
Inaudible or Unclear Audible Prompt/Feedback
162
162
Decreased Sensitivity
154
154
Battery Problem
147
147
Defective Alarm
112
112
Failure to Transmit Record
104
104
Inappropriate or Unexpected Reset
100
100
Device Displays Incorrect Message
97
97
No Device Output
86
86
Premature Discharge of Battery
82
82
Defective Component
70
70
Device Difficult to Program or Calibrate
59
59
Data Problem
54
54
Defective Device
52
52
Output Problem
51
51
Insufficient Information
51
51
Incorrect Measurement
49
49
Audible Prompt/Feedback Problem
47
47
Patient Device Interaction Problem
46
46
Overheating of Device
42
42
Display or Visual Feedback Problem
41
41
Alarm Not Visible
39
39
Therapeutic or Diagnostic Output Failure
37
37
Use of Device Problem
30
30
Low Audible Alarm
28
28
Patient-Device Incompatibility
28
28
Device-Device Incompatibility
26
26
Break
25
25
Excessive Heating
25
25
Temperature Problem
24
24
Protective Measures Problem
24
24
Biocompatibility
22
22
Incorrect, Inadequate or Imprecise Result or Readings
22
22
Melted
19
19
Smoking
16
16
Delayed Alarm
16
16
Human-Device Interface Problem
16
16
Positioning Problem
14
14
Electrical /Electronic Property Problem
14
14
Computer Software Problem
13
13
Wireless Communication Problem
13
13
No Display/Image
12
12
Mechanical Problem
12
12
No Apparent Adverse Event
12
12
Detachment of Device or Device Component
12
12
Device Fell
11
11
Failure to Sense
11
11
Fire
9
9
Thermal Decomposition of Device
9
9
Inappropriate Audible Prompt/Feedback
8
8
Noise, Audible
8
8
Computer Operating System Problem
8
8
Product Quality Problem
7
7
Circuit Failure
7
7
Disconnection
7
7
Labelling, Instructions for Use or Training Problem
7
7
Difficult to Remove
6
6
Improper Flow or Infusion
6
6
Loss of Data
6
6
Naturally Worn
6
6
Unintended Electrical Shock
5
5
Intermittent Communication Failure
5
5
Sparking
5
5
Device Difficult to Setup or Prepare
5
5
Improper or Incorrect Procedure or Method
5
5
False Alarm
5
5
False Positive Result
4
4
Loose or Intermittent Connection
4
4
Low Readings
4
4
Loss of Power
4
4
Connection Problem
4
4
Material Integrity Problem
4
4
Inadequate Instructions for Non-Healthcare Professional
4
4
Unexpected Shutdown
4
4
Packaging Problem
4
4
Patient Data Problem
4
4
Device Handling Problem
3
3
Missing Test Results
3
3
Power Problem
3
3
Complete Loss of Power
3
3
Device Dislodged or Dislocated
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Application Program Problem
3
3
Pacing Problem
3
3
Failure to Charge
3
3
Use of Incorrect Control/Treatment Settings
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6495
6495
No Known Impact Or Consequence To Patient
3881
3881
No Consequences Or Impact To Patient
1193
1193
No Patient Involvement
676
676
Unspecified Infection
230
230
Insufficient Information
195
195
Erosion
170
170
Pain
160
160
Unspecified Heart Problem
101
101
Cardiac Arrest
49
49
Skin Inflammation/ Irritation
46
46
Erythema
44
44
Death
41
41
Discomfort
40
40
Hypersensitivity/Allergic reaction
36
36
Impaired Healing
31
31
Blister
26
26
Arrhythmia
16
16
Itching Sensation
15
15
Low Oxygen Saturation
15
15
Hypoxia
14
14
Bradycardia
14
14
Purulent Discharge
14
14
Rash
13
13
Skin Irritation
13
13
Burning Sensation
12
12
Asystole
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Hemorrhage/Bleeding
11
11
Burn(s)
10
10
Swelling/ Edema
10
10
No Code Available
10
10
Bacterial Infection
9
9
Bruise/Contusion
8
8
Tachycardia
8
8
Superficial (First Degree) Burn
8
8
Twiddlers Syndrome
7
7
Skin Tears
7
7
Ventricular Fibrillation
7
7
Cardiopulmonary Arrest
7
7
Hematoma
7
7
Cellulitis
6
6
Chest Pain
6
6
Blood Loss
6
6
Diaphoresis
6
6
Loss of consciousness
6
6
Skin Erosion
5
5
Electric Shock
5
5
Atrial Fibrillation
5
5
Wound Dehiscence
5
5
Swelling
5
5
Dizziness
5
5
Local Reaction
5
5
Pocket Erosion
4
4
Failure of Implant
4
4
Stroke/CVA
4
4
Fall
4
4
Caustic/Chemical Burns
4
4
Skin Infection
4
4
Unspecified Tissue Injury
4
4
Unspecified Respiratory Problem
4
4
Skin Burning Sensation
3
3
Localized Skin Lesion
3
3
Fluid Discharge
3
3
Patient Problem/Medical Problem
3
3
Syncope/Fainting
3
3
Contact Dermatitis
3
3
Sudden Cardiac Death
3
3
Burn, Thermal
3
3
Skin Inflammation
3
3
Complaint, Ill-Defined
3
3
Injury
3
3
Headache
3
3
Fever
3
3
Low Blood Pressure/ Hypotension
3
3
Inflammation
3
3
Skin Discoloration
3
3
Pneumothorax
2
2
Rupture
2
2
Hypothermia
2
2
Scar Tissue
2
2
Increased Sensitivity
2
2
Shock
2
2
Hair Loss
2
2
High Blood Pressure/ Hypertension
2
2
Dyspnea
2
2
Cyanosis
2
2
Apnea
2
2
Irritability
2
2
Irregular Pulse
2
2
Respiratory Failure
2
2
Tissue Breakdown
2
2
Shock from Patient Lead(s)
2
2
No Information
2
2
Respiratory Arrest
2
2
Respiratory Insufficiency
1
1
Bronchial Hemorrhage
1
1
Dry Mouth
1
1
Stomach Ulceration
1
1
Cancer
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GE Healthcare, LLC
II
Dec-20-2019
2
GE Healthcare, LLC
II
Oct-23-2019
3
Philips North America, LLC
II
Jul-10-2020
4
Philips North America, LLC
II
Jun-01-2019
5
Philips North America Llc
II
May-21-2021
6
Philips North America Llc
II
Dec-08-2020
7
Preventice Services, LLC
II
Jul-01-2020
8
Spacelabs Healthcare, Inc.
II
May-03-2023
9
iRhythm Technologies, Inc.
II
Nov-04-2022
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