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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cart, emergency, cardiopulmonary (excluding equipment)
Regulation Description Cardiopulmonary emergency cart.
Product CodeBZN
Regulation Number 868.6175
Device Class 1

MDR Year MDR Reports MDR Events
2021 8 8
2022 29 29
2023 12 12
2024 7 7
2025 10 10
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 17 17
No Display/Image 13 13
Positioning Problem 6 6
Loss of Power 5 5
Output Problem 3 3
Electrical Power Problem 3 3
Electrical Shorting 3 3
Break 2 2
Unstable 1 1
Fire 1 1
Device Damaged Prior to Use 1 1
Smoking 1 1
Material Integrity Problem 1 1
Degraded 1 1
Failure to Power Up 1 1
Thermal Decomposition of Device 1 1
Difficult or Delayed Positioning 1 1
Product Quality Problem 1 1
Unintended System Motion 1 1
Connection Problem 1 1
Electrical /Electronic Property Problem 1 1
No Device Output 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 62 62
Insufficient Information 12 12
Superficial (First Degree) Burn 1 1
Sinusitis 1 1
Cough 1 1
Headache 1 1

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