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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, ultrasonic, nonfetal
Product CodeJAF
Regulation Number 892.1540
Device Class 2


Premarket Reviews
ManufacturerDecision
NEWMAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT DOPPLER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
THD SPA
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 8 8
2015 7 7
2016 5 5
2017 44 44
2018 1 1
2019 2 2
2020 5 5
2021 1 1
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Sensing Problem 44 44
Device Operates Differently Than Expected 5 5
Break 3 3
No Audible Prompt/Feedback 3 3
Device Displays Incorrect Message 3 3
Communication or Transmission Problem 2 2
Failure to Select Signal 2 2
Device Inoperable 2 2
No Display/Image 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Noise, Audible 2 2
Pressure Problem 1 1
Protective Measures Problem 1 1
Misassembly by Users 1 1
No Audible Alarm 1 1
Environmental Compatibility Problem 1 1
Inflation Problem 1 1
Loose or Intermittent Connection 1 1
Misconnection 1 1
No Device Output 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Use of Device Problem 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Defective Device 1 1
Connection Problem 1 1
Loss of Data 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 57 57
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 3 3
No Information 2 2
Air Embolism 2 2
Burn(s) 1 1
Cardiac Arrest 1 1
Death 1 1
Nausea 1 1
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Natus Neurology Inc II Jul-13-2017
2 Unetixs Vascular, Inc. II Mar-01-2023
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