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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)
Product CodeDRO
Regulation Number 870.5550
Device Class 2

MDR Year MDR Reports MDR Events
2019 93 93
2020 19 19
2021 22 22
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Pacing Problem 56 56
Material Separation 12 12
Peeled/Delaminated 9 9
Failure of Device to Self-Test 9 9
Sparking 6 6
Output Problem 6 6
Device Emits Odor 4 4
Arcing 4 4
Defibrillation/Stimulation Problem 3 3
Loss of or Failure to Bond 3 3
Failure to Capture 2 2
Failure to Deliver Shock/Stimulation 2 2
Arcing of Electrodes 2 2
No Pacing 2 2
Unexpected Shutdown 2 2
Detachment of Device or Device Component 2 2
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Battery Problem 1 1
Connection Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output below Specifications 1 1
Incomplete or Inadequate Connection 1 1
Activation Problem 1 1
Noise, Audible 1 1
Firing Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Overheating of Device 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Failure to Analyze Signal 1 1
Failure to Sense 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Fracture 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Break 1 1
Device Alarm System 1 1
Low Audible Alarm 1 1
Alarm Not Visible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 58 58
No Consequences Or Impact To Patient 26 26
No Clinical Signs, Symptoms or Conditions 17 17
No Information 14 14
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 6 6
Burn, Thermal 3 3
Superficial (First Degree) Burn 3 3
Burn(s) 3 3
Death 3 3
Bradycardia 2 2
Skin Irritation 2 2
Erythema 1 1
Partial thickness (Second Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1
Asystole 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smiths Medical ASD Inc. II Oct-13-2021
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