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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
2018 64 64
2019 93 93
2020 19 19
2021 22 22
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Pacing Problem 90 90
Failure of Device to Self-Test 14 14
Material Separation 13 13
Peeled/Delaminated 9 9
Gel Leak 7 7
Sparking 6 6
Output Problem 6 6
Detachment of Device or Device Component 5 5
Connection Problem 4 4
Defibrillation/Stimulation Problem 4 4
Arcing 4 4
Device Displays Incorrect Message 4 4
Device Emits Odor 4 4
Loss of or Failure to Bond 3 3
Appropriate Term/Code Not Available 3 3
No Pacing 2 2
Unexpected Shutdown 2 2
Failure to Capture 2 2
Failure to Deliver Shock/Stimulation 2 2
Electrical /Electronic Property Problem 2 2
Unable to Obtain Readings 2 2
Arcing of Electrodes 2 2
Device Sensing Problem 2 2
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Battery Problem 1 1
Capturing Problem 1 1
Failure to Analyze Signal 1 1
Failure to Sense 1 1
Product Quality Problem 1 1
Inaccurate Synchronization 1 1
Fire 1 1
Fracture 1 1
Material Fragmentation 1 1
Energy Output Problem 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
Intermittent Continuity 1 1
Break 1 1
Device Alarm System 1 1
Low Audible Alarm 1 1
Alarm Not Visible 1 1
Failure To Adhere Or Bond 1 1
Signal Artifact/Noise 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
Inadequate User Interface 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output below Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 93 93
No Consequences Or Impact To Patient 35 35
No Information 25 25
No Clinical Signs, Symptoms or Conditions 17 17
No Known Impact Or Consequence To Patient 12 12
Burn(s) 6 6
Death 5 5
Insufficient Information 5 5
Burn, Thermal 3 3
Skin Irritation 2 2
Partial thickness (Second Degree) Burn 2 2
Superficial (First Degree) Burn 2 2
Bradycardia 2 2
No Code Available 1 1
Asystole 1 1
Full thickness (Third Degree) Burn 1 1

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