• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, network and communication, physiological monitors
Product CodeMSX
Regulation Number 870.2300
Device Class 2


Premarket Reviews
ManufacturerDecision
AIRSTRIP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERTWATCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOFOURMIS SINGAPORE PTE. LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOFOURMIS SINGAPORE PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOXVIEW, LLC
  SUBSTANTIALLY EQUIVALENT 1
CORSANO HEALTH B.V.
  SUBSTANTIALLY EQUIVALENT 1
CRITICAL ALERT
  SUBSTANTIALLY EQUIVALENT 1
CURRENT HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CURRENT HEALTH LTD
  SUBSTANTIALLY EQUIVALENT 2
CURRENT HEALTH LTD.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  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
SPIRE, INC. D/B/A SPIRE HEALTH
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISICU, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZYTER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 25 25
2021 17 17
2022 18 18
2023 10 10
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 38 38
No Audible Alarm 29 29
Alarm Not Visible 9 9
Delayed Alarm 4 4
Wireless Communication Problem 3 3
Defective Alarm 3 3
Disconnection 2 2
Fire 2 2
No Visual Prompts/Feedback 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 1 1
Patient Data Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Operating System Becomes Nonfunctional 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Intermittent Communication Failure 1 1
Melted 1 1
Misconnection 1 1
Failure to Transmit Record 1 1
Smoking 1 1
Improper or Incorrect Procedure or Method 1 1
High Readings 1 1
Inappropriate Waveform 1 1
Application Network Problem 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Electrical /Electronic Property Problem 1 1
Low Audible Alarm 1 1
Computer Software Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 28 28
No Clinical Signs, Symptoms or Conditions 27 27
No Known Impact Or Consequence To Patient 15 15
No Consequences Or Impact To Patient 7 7
Death 6 6
Asystole 4 4
Cardiac Arrest 3 3
Cardiopulmonary Arrest 3 3
Chest Pain 2 2
Low Oxygen Saturation 2 2
Sudden Cardiac Death 1 1
Loss Of Pulse 1 1
No Patient Involvement 1 1
Dyspnea 1 1
Tachycardia 1 1
Ventricular Tachycardia 1 1
Respiratory Arrest 1 1
Bradycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mindray DS USA, Inc. dba Mindray North America III Jul-21-2021
2 Mindray DS USA, Inc. dba Mindray North America II Mar-15-2021
3 Philips North America II Mar-27-2024
4 Philips North America Llc II Feb-01-2022
-
-