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TPLC
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Device
monitor, cardiac (incl. cardiotachometer & rate alarm)
Product Code
DRT
Regulation Number
870.2300
Device Class
2
Premarket Reviews
Manufacturer
Decision
CONNECTED SENSING- A DIVISION OF PHILIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
IVY BIOMEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
NETEERA TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
1
SLEEPIZ AG
SUBSTANTIALLY EQUIVALENT
1
VIOS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
XANDAR KARDIAN INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
224
224
2019
447
447
2020
50
50
2021
85
85
2022
39
39
2023
47
47
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unable to Obtain Readings
469
469
Overheating of Device
138
138
Temperature Problem
105
105
Output Problem
85
85
Communication or Transmission Problem
42
42
Incorrect, Inadequate or Imprecise Result or Readings
42
42
Device Displays Incorrect Message
27
27
Protective Measures Problem
18
18
Misassembly by Users
16
16
Device Issue
15
15
No Audible Alarm
15
15
Battery Problem
14
14
Failure of Device to Self-Test
14
14
Power Problem
13
13
Application Program Problem
13
13
Structural Problem
10
10
Human Factors Issue
10
10
Data Problem
10
10
Device Alarm System
10
10
Defibrillation/Stimulation Problem
10
10
Patient Data Problem
9
9
Electrical /Electronic Property Problem
7
7
Display or Visual Feedback Problem
7
7
Complete Loss of Power
7
7
Appropriate Term/Code Not Available
6
6
No Device Output
6
6
Failure to Read Input Signal
6
6
Loss of Data
6
6
Use of Device Problem
5
5
Computer Software Problem
5
5
Intermittent Communication Failure
5
5
Unexpected Shutdown
4
4
Patient Device Interaction Problem
4
4
No Display/Image
4
4
Pacing Problem
4
4
Incorrect Measurement
4
4
Device Sensing Problem
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Device Operates Differently Than Expected
3
3
Device Operational Issue
3
3
Low Readings
3
3
Inappropriate/Inadequate Shock/Stimulation
3
3
Intermittent Loss of Power
3
3
Unintended Electrical Shock
3
3
Failure to Select Signal
2
2
Incorrect Interpretation of Signal
2
2
Break
2
2
Thermal Decomposition of Device
2
2
Failure to Deliver Shock/Stimulation
2
2
Defective Alarm
2
2
Signal Artifact/Noise
2
2
Insufficient Information
2
2
Wireless Communication Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Electrical Shorting
1
1
Human-Device Interface Problem
1
1
Improper Alarm
1
1
Improper Device Output
1
1
Improper or Incorrect Procedure or Method
1
1
No Audible Prompt/Feedback
1
1
Defective Component
1
1
Invalid Sensing
1
1
Defective Device
1
1
High Readings
1
1
Premature Discharge of Battery
1
1
Alarm Not Visible
1
1
Accessory Incompatible
1
1
Delayed Alarm
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Failure to Discharge
1
1
Application Program Problem: Dose Calculation Error
1
1
Failure to Charge
1
1
Use of Incorrect Control/Treatment Settings
1
1
Failure to Sense
1
1
Output above Specifications
1
1
Grounding Malfunction
1
1
Failure to Power Up
1
1
Unintended Application Program Shut Down
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
344
344
No Clinical Signs, Symptoms or Conditions
216
216
No Consequences Or Impact To Patient
142
142
No Known Impact Or Consequence To Patient
106
106
No Information
94
94
Death
22
22
Cardiac Arrest
4
4
Tachycardia
2
2
Injury
2
2
Loss of consciousness
2
2
Unspecified Heart Problem
2
2
Unspecified Tissue Injury
2
2
Insufficient Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Low Oxygen Saturation
1
1
Burn, Thermal
1
1
Electric Shock
1
1
Loss Of Pulse
1
1
No Code Available
1
1
Patient Problem/Medical Problem
1
1
Anxiety
1
1
Fever
1
1
Low Blood Pressure/ Hypotension
1
1
Respiratory Distress Syndrome of Newborns
1
1
Skin Discoloration
1
1
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