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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device support, breathing tube
Product CodeJAY
Regulation Number 868.5280
Device Class 1

MDR Year MDR Reports MDR Events
2019 26 26
2020 25 25
2021 17 17
2022 11 11
2023 11 11
2024 4 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 19 19
Therapeutic or Diagnostic Output Failure 12 12
Failure to Sense 12 12
Loss of or Failure to Bond 8 8
Break 7 7
Loose or Intermittent Connection 7 7
Device Sensing Problem 6 6
Device Dislodged or Dislocated 4 4
Unintended Movement 3 3
Defective Component 3 3
Device Slipped 2 2
Disconnection 2 2
Migration 2 2
Device Markings/Labelling Problem 2 2
Component Missing 2 2
Protective Measures Problem 2 2
Device Displays Incorrect Message 2 2
Leak/Splash 1 1
Output Problem 1 1
Entrapment of Device 1 1
Material Disintegration 1 1
Insufficient Information 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Premature Separation 1 1
Device Damaged Prior to Use 1 1
Device Alarm System 1 1
Positioning Problem 1 1
Ventilation Problem in Device Environment 1 1
Patient Device Interaction Problem 1 0
Material Fragmentation 1 1
Material Discolored 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 36 36
No Clinical Signs, Symptoms or Conditions 29 29
Insufficient Information 8 8
Foreign Body In Patient 7 7
Vomiting 7 7
Low Oxygen Saturation 3 3
Tooth Fracture 2 1
Unspecified Tissue Injury 2 2
No Consequences Or Impact To Patient 2 2
High Blood Pressure/ Hypertension 1 1
Necrosis 1 1
No Information 1 1
Laceration(s) 1 1
Hemorrhage/Bleeding 1 1
Pressure Sores 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Nov-10-2022
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