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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calculator, pulmonary function data
Regulation Description Pulmonary-function data calculator.
Product CodeBZC
Regulation Number 868.1880
Device Class 2


Premarket Reviews
ManufacturerDecision
TECHBOPULM, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 5 5
2022 9 9
2023 8 8
2024 8 8
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 8 8
Detachment of Device or Device Component 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Electrical Shorting 2 2
Break 2 2
Computer Software Problem 2 2
Insufficient Information 2 2
Smoking 2 2
Overheating of Device 2 2
Battery Problem 1 1
Contamination /Decontamination Problem 1 1
Device Dislodged or Dislocated 1 1
Environmental Particulates 1 1
Component Incompatible 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Gas Output Problem 1 1
Material Integrity Problem 1 1
Temperature Problem 1 1
Explosion 1 1
Intermittent Communication Failure 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Abrasion 4 4
Dyspnea 3 3
Discomfort 2 2
No Patient Involvement 1 1
Convulsion/Seizure 1 1
Laceration(s) 1 1
Dizziness 1 1
Sore Throat 1 1
Loss of consciousness 1 1
Tooth Fracture 1 1
Decreased Respiratory Rate 1 1
Bruise/Contusion 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Vyaire Medical, Inc. I May-08-2024
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