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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
MURATA VIOS, INC.
SUBSTANTIALLY EQUIVALENT
1
NETEERA TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
2
SLEEPIZ AG
SUBSTANTIALLY EQUIVALENT
1
XANDAR KARDIAN INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
447
447
2020
50
50
2021
85
85
2022
39
39
2023
69
69
2024
24
24
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unable to Obtain Readings
348
348
Overheating of Device
101
101
Output Problem
95
95
Temperature Problem
89
89
Communication or Transmission Problem
46
46
Incorrect, Inadequate or Imprecise Result or Readings
37
37
Protective Measures Problem
22
22
Power Problem
20
20
No Audible Alarm
18
18
Battery Problem
16
16
Display or Visual Feedback Problem
15
15
Application Program Problem
14
14
Data Problem
12
12
Patient Data Problem
12
12
Complete Loss of Power
11
11
Structural Problem
10
10
No Device Output
9
9
Intermittent Communication Failure
9
9
Device Alarm System
8
8
Signal Artifact/Noise
6
6
Electrical /Electronic Property Problem
6
6
Failure of Device to Self-Test
6
6
Loss of Data
6
6
Image Display Error/Artifact
5
5
Computer Software Problem
5
5
Erratic or Intermittent Display
4
4
No Display/Image
4
4
Pacing Problem
4
4
Defibrillation/Stimulation Problem
4
4
Failure to Read Input Signal
4
4
Unexpected Shutdown
4
4
Patient Device Interaction Problem
4
4
Appropriate Term/Code Not Available
3
3
Intermittent Loss of Power
3
3
Unintended Electrical Shock
3
3
Wireless Communication Problem
3
3
Low Readings
3
3
Device Displays Incorrect Message
3
3
Incorrect Measurement
3
3
Failure to Select Signal
2
2
Use of Device Problem
2
2
Failure to Deliver Shock/Stimulation
2
2
Break
2
2
Alarm Not Visible
2
2
No Audible Prompt/Feedback
2
2
High Readings
2
2
Device Sensing Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Contamination /Decontamination Problem
2
2
Electrical Shorting
1
1
Application Network Problem
1
1
Defective Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
Insufficient Information
1
1
Audible Prompt/Feedback Problem
1
1
Unintended Application Program Shut Down
1
1
Erratic Results
1
1
Accessory Incompatible
1
1
Delayed Alarm
1
1
Failure to Charge
1
1
Premature Discharge of Battery
1
1
Use of Incorrect Control/Treatment Settings
1
1
Application Program Problem: Dose Calculation Error
1
1
Improper or Incorrect Procedure or Method
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Failure to Power Up
1
1
Grounding Malfunction
1
1
Incorrect Interpretation of Signal
1
1
Failure to Sense
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
262
262
No Patient Involvement
247
247
No Consequences Or Impact To Patient
120
120
No Information
55
55
No Known Impact Or Consequence To Patient
51
51
Death
12
12
Cardiac Arrest
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Tachycardia
2
2
Unspecified Heart Problem
2
2
Unspecified Tissue Injury
2
2
Insufficient Information
2
2
Fever
1
1
Low Blood Pressure/ Hypotension
1
1
Respiratory Distress Syndrome of Newborns
1
1
Skin Discoloration
1
1
Injury
1
1
Loss of consciousness
1
1
Low Oxygen Saturation
1
1
Electric Shock
1
1
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