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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, network and communication, physiological monitors
Regulation Description Cardiac monitor (including cardiotachometer and rate alarm).
Product CodeMSX
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSTRIP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERTWATCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCOM SWEDEN AB
  SUBSTANTIALLY EQUIVALENT 1
ASCOM UMS SRL UNIPERSONALE
  SUBSTANTIALLY EQUIVALENT 1
ATHENA GTX
  SUBSTANTIALLY EQUIVALENT 1
BOXVIEW, LLC
  SUBSTANTIALLY EQUIVALENT 1
CRITICAL ALERT
  SUBSTANTIALLY EQUIVALENT 1
CURRENT HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CURRENT HEALTH LTD
  SUBSTANTIALLY EQUIVALENT 1
CURRENT HEALTH LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SNAP40 LTD
  SUBSTANTIALLY EQUIVALENT 1
SPIRE, INC. D/B/A SPIRE HEALTH
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISICU, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 11 11
2017 16 16
2018 15 15
2019 15 15
2020 25 25
2021 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 21 21
Device Operates Differently Than Expected 14 14
Device Alarm System 13 13
Alarm Not Visible 10 10
Adverse Event Without Identified Device or Use Problem 5 5
Device Operational Issue 3 3
No Display/Image 3 3
Defective Alarm 3 3
Delayed Alarm 3 3
Disconnection 2 2
Computer Software Problem 2 2
Fire 2 2
Electrical /Electronic Property Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Device Inoperable 2 2
Communication or Transmission Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 2 2
Positioning Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Patient Data Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Wireless Communication Problem 1 1
No Visual Prompts/Feedback 1 1
Intermittent Communication Failure 1 1
Connection Problem 1 1
Loss of Data 1 1
Use of Device Problem 1 1
Operating System Becomes Nonfunctional 1 1
Inappropriate Waveform 1 1
Split 1 1
Device Displays Incorrect Message 1 1
Application Network Problem 1 1
Battery Problem 1 1
False Device Output 1 1
Display or Visual Feedback Problem 1 1
Electromagnetic Interference 1 1
Melted 1 1
Misconnection 1 1
Unintended System Motion 1 1
No Device Output 1 1
Overheating of Device 1 1
Failure to Transmit Record 1 1
Failure to Sense 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Smoking 1 1
Use of Incorrect Control Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 28 28
Death 20 20
No Consequences Or Impact To Patient 14 14
No Clinical Signs, Symptoms or Conditions 13 13
Cardiopulmonary Arrest 4 4
Bradycardia 3 3
Chest Pain 2 2
Low Oxygen Saturation 2 2
No Information 2 2
Cardiac Arrest 2 2
No Patient Involvement 2 2
No Code Available 1 1
Insufficient Information 1 1
Sudden Cardiac Death 1 1
Loss Of Pulse 1 1
Discomfort 1 1
Burn(s) 1 1
Dyspnea 1 1
Erythema 1 1
Low Blood Pressure/ Hypotension 1 1
Sepsis 1 1
Ventricular Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ascom US, INC. II May-10-2016
2 Mindray DS USA, Inc. dba Mindray North America III Jul-21-2021
3 Mindray DS USA, Inc. dba Mindray North America II Mar-15-2021
4 Mindray DS USA, Inc. dba Mindray North America II Feb-08-2018
5 Philips Electronics North America Corporation II Dec-21-2017
6 Spacelabs Healthcare Inc II Jan-25-2018
7 Vidco, Inc. II Jan-04-2016
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