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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pacemaker, cardiac, external transcutaneous (non-invasive)
Regulation Description External transcutaneous cardiac pacemaker (noninvasive).
Product CodeDRO
Regulation Number 870.5550
Device Class 2

Device Problems
Pacing Problem 102
Device Displays Incorrect Message 23
Failure of Device to Self-Test 15
Gel Leak 14
Output Problem 8
Material Separation 6
Device Operates Differently Than Expected 5
Connection Problem 4
Delamination 4
Loss of or Failure to Bond 3
Failure to Capture 3
Defibrillation Problem 3
Unable to Obtain Readings 2
Detachment of Device or device Component 2
Arcing of Electrodes 2
Appropriate Term/Code Not Available 2
Electrical /Electronic Property Problem 2
Output above Specifications 1
Inappropriate or Unexpected Reset 1
Output below Specifications 1
Activation Problem 1
Signal Artifact 1
Capturing Problem 1
Failure to Charge 1
Energy Output Problem 1
Inappropriate Shock 1
Device Sensing Problem 1
Improper Device Output 1
Material Integrity Problem 1
Failure To Adhere Or Bond 1
Programming Issue 1
Inaccurate Synchronization 1
Sparking 1
Inadequate User Interface 1
Break 1
Firing Problem 1
Patient Device Interaction Problem 1
Unexpected Shutdown 1
Material Fragmentation 1
Incomplete or Inadequate Connection 1
Electrical Shorting 1
Total Device Problems 224

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Sep-02-2015

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