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TPLC
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Device
monitor, cardiac (incl. cardiotachometer & rate alarm)
Regulation Description
Cardiac monitor (including cardiotachometer and rate alarm).
Product Code
DRT
Regulation Number
870.2300
Device Class
2
Premarket Reviews
Manufacturer
Decision
CIRCADIA TECHNOLOGIES, LTD.
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
2020
50
50
2021
85
85
2022
38
38
2023
59
59
2024
30
30
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output Problem
86
86
Overheating of Device
49
49
Temperature Problem
47
47
Communication or Transmission Problem
38
38
Incorrect, Inadequate or Imprecise Result or Readings
32
32
Power Problem
18
18
Protective Measures Problem
16
16
Battery Problem
14
14
Display or Visual Feedback Problem
13
13
Patient Data Problem
13
13
No Audible Alarm
13
13
Application Program Problem
12
12
Data Problem
11
11
Complete Loss of Power
9
9
Intermittent Communication Failure
9
9
Loss of Data
6
6
Signal Artifact/Noise
6
6
Unable to Obtain Readings
6
6
No Device Output
6
6
Computer Software Problem
5
5
Electrical /Electronic Property Problem
5
5
Intermittent Loss of Power
4
4
Image Display Error/Artifact
4
4
Appropriate Term/Code Not Available
3
3
Unexpected Shutdown
3
3
Pacing Problem
3
3
Patient Device Interaction Problem
3
3
No Display/Image
3
3
Device Alarm System
3
3
Erratic or Intermittent Display
3
3
Low Readings
2
2
Break
2
2
Unintended Electrical Shock
2
2
Failure to Select Signal
2
2
Device Sensing Problem
2
2
Contamination /Decontamination Problem
2
2
Unintended Application Program Shut Down
2
2
Device Displays Incorrect Message
2
2
Alarm Not Visible
2
2
High Readings
2
2
Delayed Alarm
1
1
Erratic Results
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Premature Discharge of Battery
1
1
Application Network Problem
1
1
Failure to Deliver Shock/Stimulation
1
1
Wireless Communication Problem
1
1
No Audible Prompt/Feedback
1
1
Grounding Malfunction
1
1
Application Program Problem: Dose Calculation Error
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
245
245
No Consequences Or Impact To Patient
22
22
No Known Impact Or Consequence To Patient
13
13
No Patient Involvement
3
3
Insufficient Information
2
2
Unspecified Heart Problem
2
2
Tachycardia
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Unspecified Tissue Injury
2
2
Cardiac Arrest
1
1
Respiratory Distress Syndrome of Newborns
1
1
Fever
1
1
Low Oxygen Saturation
1
1
Low Blood Pressure/ Hypotension
1
1
Loss of consciousness
1
1
Injury
1
1
Skin Discoloration
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Murata Vios, Inc.
II
Feb-12-2025
2
Murata Vios, Inc.
II
Jan-30-2025
3
Murata Vios, Inc.
II
Jan-16-2025
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