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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2
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 2
DRAEGER MEDICAL SYSTEMS, INC.
  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 2
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 2
VISICU, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZYTER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 11 11
2017 16 16
2018 15 15
2019 15 15
2020 25 25
2021 17 17
2022 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 29 29
Device Alarm System 22 22
Device Operates Differently Than Expected 14 14
Alarm Not Visible 11 11
Adverse Event Without Identified Device or Use Problem 5 5
Delayed Alarm 4 4
Defective Alarm 3 3
Device Operational Issue 3 3
No Display/Image 3 3
Improper or Incorrect Procedure or Method 3 3
Electrical /Electronic Property Problem 2 2
Device Inoperable 2 2
Communication or Transmission Problem 2 2
Disconnection 2 2
Computer Software Problem 2 2
Fire 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
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/Treatment Settings 1 1
Connection Problem 1 1
Loss of Data 1 1
Use of Device Problem 1 1
Operating System Becomes Nonfunctional 1 1
False Device Output 1 1
Display or Visual Feedback Problem 1 1
Electromagnetic Interference 1 1
Inappropriate Waveform 1 1
Split 1 1
Device Displays Incorrect Message 1 1
Application Network Problem 1 1
Battery Problem 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 Clinical Signs, Symptoms or Conditions 19 19
No Consequences Or Impact To Patient 14 14
Insufficient Information 12 12
Cardiopulmonary Arrest 4 4
Bradycardia 3 3
Asystole 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
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
Respiratory Arrest 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 Philips North America Llc II Feb-01-2022
7 Spacelabs Healthcare Inc II Jan-25-2018
8 Vidco, Inc. II Jan-04-2016
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