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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
1. K181165
Philips wearable biosensor-G5 Solution
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
Patient Data Problem
12
12
Data Problem
12
12
Complete Loss of Power
11
11
Structural Problem
10
10
Intermittent Communication Failure
9
9
No Device Output
9
9
Device Alarm System
8
8
Failure of Device to Self-Test
6
6
Electrical /Electronic Property Problem
6
6
Signal Artifact/Noise
6
6
Loss of Data
6
6
Image Display Error/Artifact
5
5
Computer Software Problem
5
5
Pacing Problem
4
4
Defibrillation/Stimulation Problem
4
4
Erratic or Intermittent Display
4
4
Unexpected Shutdown
4
4
Patient Device Interaction Problem
4
4
Failure to Read Input Signal
4
4
No Display/Image
4
4
Appropriate Term/Code Not Available
3
3
Incorrect Measurement
3
3
Device Displays Incorrect Message
3
3
Low Readings
3
3
Unintended Electrical Shock
3
3
Intermittent Loss of Power
3
3
Wireless Communication Problem
3
3
Alarm Not Visible
2
2
Failure to Select Signal
2
2
No Audible Prompt/Feedback
2
2
Break
2
2
Failure to Deliver Shock/Stimulation
2
2
Device Sensing Problem
2
2
High Readings
2
2
Contamination /Decontamination Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Use of Device Problem
2
2
Therapeutic or Diagnostic Output Failure
1
1
Erratic Results
1
1
Failure to Charge
1
1
Application Program Problem: Dose Calculation Error
1
1
Premature Discharge of Battery
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Improper or Incorrect Procedure or Method
1
1
Unintended Application Program Shut Down
1
1
Failure to Sense
1
1
Insufficient Information
1
1
Defective Device
1
1
Grounding Malfunction
1
1
Audible Prompt/Feedback Problem
1
1
Electrical Shorting
1
1
Accessory Incompatible
1
1
Application Network Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Failure to Power Up
1
1
Incorrect Interpretation of Signal
1
1
Delayed Alarm
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Cardiac Arrest
3
3
Insufficient Information
2
2
Unspecified Heart Problem
2
2
Unspecified Tissue Injury
2
2
Tachycardia
2
2
Respiratory Distress Syndrome of Newborns
1
1
Skin Discoloration
1
1
Low Oxygen Saturation
1
1
Loss of consciousness
1
1
Low Blood Pressure/ Hypotension
1
1
Electric Shock
1
1
Fever
1
1
Injury
1
1
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