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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
CRITICARE SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
FLUKE BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
4
1. K103336
MPS450 MULTIPARAMETER SIMULATOR
2. K110429
PROSIM 4, PROSIM 6, PROSIM 8
3. K121722
ESA620 ELECTRICAL SAFETY ANALYZER
4. K121860
ESA615
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
24
24
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unable to Obtain Readings
511
511
Overheating of Device
179
179
Temperature Problem
151
151
Output Problem
106
106
Device Displays Incorrect Message
82
82
Communication or Transmission Problem
57
57
Incorrect, Inadequate or Imprecise Result or Readings
52
52
Device Operates Differently Than Expected
42
42
Failure of Device to Self-Test
23
23
Protective Measures Problem
23
23
No Audible Alarm
22
22
Power Problem
20
20
Battery Problem
19
19
Device Alarm System
19
19
Device Issue
18
18
Loss of Power
17
17
Misassembly by Users
16
16
Application Program Problem
15
15
Display or Visual Feedback Problem
15
15
Patient Data Problem
13
13
Data Problem
12
12
Device Operational Issue
12
12
Complete Loss of Power
11
11
Defibrillation/Stimulation Problem
11
11
Device Inoperable
11
11
Failure to Read Input Signal
10
10
Structural Problem
10
10
Human Factors Issue
10
10
Device Sensing Problem
9
9
Intermittent Communication Failure
9
9
No Device Output
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
Signal Artifact/Noise
7
7
Image Display Error/Artifact
6
6
Incorrect Measurement
6
6
Invalid Sensing
6
6
Loss of Data
6
6
Appropriate Term/Code Not Available
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Smoking
5
5
Use of Device Problem
5
5
Computer Software Problem
5
5
Erratic or Intermittent Display
4
4
Melted
4
4
Inappropriate/Inadequate Shock/Stimulation
4
4
Incorrect Interpretation of Signal
4
4
Patient Device Interaction Problem
4
4
Unexpected Shutdown
4
4
Intermittent Loss of Power
3
3
Unintended Electrical Shock
3
3
Wireless Communication Problem
3
3
Device Handling Problem
3
3
Low Readings
3
3
Failure to Analyze Signal
3
3
Failure to Power Up
3
3
Break
3
3
Alarm Not Visible
3
3
Premature Discharge of Battery
2
2
Defective Alarm
2
2
Failure to Deliver Shock/Stimulation
2
2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Failure to Discharge
2
2
Device Emits Odor
2
2
Failure to Transmit Record
2
2
Self-Activation or Keying
2
2
Failure to Sense
2
2
Radiofrequency Interference (RFI)
2
2
No Audible Prompt/Feedback
2
2
Incorrect Or Inadequate Test Results
2
2
High Readings
2
2
Contamination /Decontamination Problem
2
2
Improper Alarm
2
2
Improper Device Output
2
2
Insufficient Information
2
2
Material Integrity Problem
2
2
Unintended Application Program Shut Down
2
2
Erratic Results
1
1
Audible Prompt/Feedback Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Operating System Becomes Nonfunctional
1
1
Programming Issue
1
1
Noise, Audible
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Human-Device Interface Problem
1
1
Electrical Shorting
1
1
Sparking
1
1
Application Network Problem
1
1
Arcing
1
1
Defective Device
1
1
Defective Component
1
1
Improper or Incorrect Procedure or Method
1
1
Electro-Static Discharge
1
1
Tidal Volume Fluctuations
1
1
Device Slipped
1
1
Material Separation
1
1
Increase in Pressure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
416
416
No Clinical Signs, Symptoms or Conditions
264
264
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
Tachycardia
2
2
Unspecified Heart Problem
2
2
Unspecified Tissue Injury
2
2
Insufficient Information
2
2
Electric Shock
2
2
Injury
2
2
Loss of consciousness
2
2
Low Oxygen Saturation
1
1
Sudden Cardiac Death
1
1
Burn, Thermal
1
1
Loss Of Pulse
1
1
Patient Problem/Medical Problem
1
1
Burn(s)
1
1
Anxiety
1
1
Complaint, Ill-Defined
1
1
Fever
1
1
Head Injury
1
1
Low Blood Pressure/ Hypotension
1
1
Respiratory Distress
1
1
Respiratory Distress Syndrome of Newborns
1
1
Skin Discoloration
1
1
No Code Available
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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