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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

MDR Year MDR Reports MDR Events
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
No Audible Prompt/Feedback 3 3
Break 2 2
No Display/Image 1 1
Inflation Problem 1 1
Misconnection 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Defective Device 1 1
Loss of Data 1 1
Device Sensing Problem 1 1
Environmental Compatibility Problem 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Air Embolism 2 2
Cardiac Arrest 1 1
Nausea 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Unetixs Vascular, Inc. II Mar-01-2023
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