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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
CIRCADIA TECHNOLOGIES, LTD.
SUBSTANTIALLY EQUIVALENT
1
CONNECTED SENSING- A DIVISION OF PHILIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
CRITICARE SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
FLUKE BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
4
HOANA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
IVY BIOMEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
IVY BIOMEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
5
MURATA VIOS, INC.
SUBSTANTIALLY EQUIVALENT
1
NETEERA TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
2
SLEEPIZ AG
SUBSTANTIALLY EQUIVALENT
1
VIOS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
WIRELESS 2000 RF & UWB TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
1
WR MEDICAL ELECTRONICS CO.
SUBSTANTIALLY EQUIVALENT
1
XANDAR KARDIAN INC.
SUBSTANTIALLY EQUIVALENT
1
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
26
26
2015
48
48
2016
55
55
2017
159
159
2018
224
224
2019
447
447
2020
50
50
2021
85
85
2022
39
39
2023
69
69
2024
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unable to Obtain Readings
514
514
Overheating of Device
179
179
Temperature Problem
151
151
Output Problem
111
111
Device Displays Incorrect Message
82
82
Communication or Transmission Problem
57
57
Incorrect, Inadequate or Imprecise Result or Readings
54
54
Device Operates Differently Than Expected
42
42
Protective Measures Problem
26
26
No Audible Alarm
26
26
Failure of Device to Self-Test
23
23
Power Problem
22
22
Battery Problem
20
20
Device Alarm System
20
20
Device Issue
18
18
Loss of Power
17
17
Misassembly by Users
16
16
Application Program Problem
16
16
Display or Visual Feedback Problem
15
15
Patient Data Problem
15
15
Device Operational Issue
12
12
Data Problem
12
12
Defibrillation/Stimulation Problem
11
11
Complete Loss of Power
11
11
Device Inoperable
11
11
Failure to Read Input Signal
10
10
Intermittent Communication Failure
10
10
Structural Problem
10
10
Human Factors Issue
10
10
No Device Output
9
9
Device Sensing Problem
9
9
Thermal Decomposition of Device
9
9
Electrical /Electronic Property Problem
8
8
No Display/Image
8
8
Pacing Problem
8
8
Failure to Select Signal
7
7
Image Display Error/Artifact
7
7
Signal Artifact/Noise
7
7
Adverse Event Without Identified Device or Use Problem
6
6
Invalid Sensing
6
6
Loss of Data
6
6
Appropriate Term/Code Not Available
6
6
Incorrect Measurement
6
6
Use of Device Problem
5
5
Computer Software Problem
5
5
Unexpected Shutdown
5
5
Smoking
5
5
Melted
4
4
Incorrect Interpretation of Signal
4
4
Inappropriate/Inadequate Shock/Stimulation
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
416
416
No Clinical Signs, Symptoms or Conditions
278
278
No Known Impact Or Consequence To Patient
246
246
No Consequences Or Impact To Patient
176
176
No Information
133
133
Death
35
35
Cardiac Arrest
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Electric Shock
2
2
Injury
2
2
Insufficient Information
2
2
Unspecified Tissue Injury
2
2
Tachycardia
2
2
Unspecified Heart Problem
2
2
Loss of consciousness
2
2
Patient Problem/Medical Problem
1
1
Complaint, Ill-Defined
1
1
Respiratory Distress
1
1
No Code Available
1
1
Head Injury
1
1
Burn, Thermal
1
1
Skin Discoloration
1
1
Burn(s)
1
1
Loss Of Pulse
1
1
Fever
1
1
Sudden Cardiac Death
1
1
Anxiety
1
1
Respiratory Distress Syndrome of Newborns
1
1
Low Blood Pressure/ Hypotension
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
II
Aug-19-2014
2
Mindray DS USA, Inc. d.b.a. Mindray North America
II
Feb-24-2012
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