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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device adaptor, lead switching, electrocardiograph
Regulation Description Electrocardiograph lead switching adaptor.
Product CodeDRW
Regulation Number 870.2350
Device Class 2

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Prong 1 1
Incorrect Or Inadequate Test Results 1 1
Device Displays Incorrect Message 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
No Information 1 1

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