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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
2014 2 2
2015 41 41
2016 49 49
2017 15 15
2018 64 64
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 111 111
Device Displays Incorrect Message 35 35
Device Operates Differently Than Expected 17 17
Failure of Device to Self-Test 15 15
Gel Leak 14 14
Material Separation 13 13
Output Problem 11 11
Peeled/Delaminated 10 10
Sparking 7 7
Defibrillation/Stimulation Problem 5 5
Electrical /Electronic Property Problem 5 5
Failure to Capture 5 5
Detachment of Device or Device Component 5 5
Device Emits Odor 4 4
Arcing 4 4
Connection Problem 4 4
Delamination 4 4
Device Sensing Problem 3 3
Appropriate Term/Code Not Available 3 3
No Pacing 3 3
Loss of or Failure to Bond 3 3
Failure to Charge 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Unable to Obtain Readings 2 2
Noise, Audible 2 2
Unexpected Shutdown 2 2
Inappropriate or Unexpected Reset 2 2
Failure to Deliver Shock/Stimulation 2 2
Communication or Transmission Problem 2 2
Arcing of Electrodes 2 2
Failure to Align 1 1
Low Battery 1 1
Battery Problem 1 1
Capturing Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output below Specifications 1 1
Programming Issue 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Incomplete or Inadequate Connection 1 1
Activation Problem 1 1
Improper Device Output 1 1
Inadequate User Interface 1 1
Firing Problem 1 1
Failure to Analyze Signal 1 1
Self-Activation or Keying 1 1
Failure to Sense 1 1
Smoking 1 1
Inaccurate Synchronization 1 1
Improper or Incorrect Procedure or Method 1 1
Energy Output Problem 1 1
Output above Specifications 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Product Quality Problem 1 1
Pacing Intermittently 1 1
Intermittent Continuity 1 1
Use of Incorrect Control/Treatment Settings 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
Break 1 1
Loose or Intermittent Connection 1 1
Fire 1 1
Fracture 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 154 154
No Known Impact Or Consequence To Patient 45 45
No Consequences Or Impact To Patient 42 42
No Information 27 27
No Clinical Signs, Symptoms or Conditions 17 17
Burn(s) 7 7
Insufficient Information 6 6
Death 5 5
Burn, Thermal 3 3
Superficial (First Degree) Burn 3 3
Bradycardia 2 2
Skin Irritation 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 1 1
Shock from Patient Lead(s) 1 1
No Code Available 1 1
Lymphoma 1 1
Asystole 1 1
Erythema 1 1
Weight Changes 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Sep-02-2015
2 Covidien LLC I Oct-15-2014
3 Covidien LLC II Apr-29-2013
4 Smiths Medical ASD Inc. II Oct-13-2021
5 TZ Medical Inc. II May-30-2013
6 Welch Allyn Protocol, Inc II Jan-24-2011
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