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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device anesthesia breathing circuit kit (adult & pediatric)
Regulation Description Anesthesia breathing circuit.
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOFP
Regulation Number 868.5240
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2018 1 1
2019 7 7
2020 17 17
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7 7
Connection Problem 4 4
Material Integrity Problem 2 2
Defective Component 2 2
Fracture 2 2
Crack 2 2
Filling Problem 1 1
Material Fragmentation 1 1
Gas Output Problem 1 1
Hole In Material 1 1
Mechanical Problem 1 1
Separation Failure 1 1
Defective Device 1 1
Blocked Connection 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1
Gas Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Pressure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Loose or Intermittent Connection 1 1
Fitting Problem 1 1
Device Alarm System 1 1
Coagulation in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 12 12
Hypoxia 4 4
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Low Oxygen Saturation 2 2
No Information 2 2
Death 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Loss Of Pulse 1 1
Bronchospasm 1 1
Awareness during Anaesthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. II Mar-05-2021
2 Draeger Medical, Inc. I Jan-24-2019
3 Intersurgical Inc II Dec-30-2020
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