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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dc-defibrillator, high energy, (including paddles)
Definition PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
Product CodeDRK
Regulation Number 870.5300
Device Class 3

MDR Year MDR Reports MDR Events
2015 1 1
2019 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1 1
Defibrillation/Stimulation Problem 1 1
Device-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Operating System Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 2 2
No Information 1 1
Insufficient Information 1 1

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