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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
Failure to Capture 5 5
Electrical /Electronic Property Problem 5 5
Detachment of Device or Device Component 5 5
Defibrillation/Stimulation Problem 5 5
Arcing 4 4
Device Emits Odor 4 4
Connection Problem 4 4
Delamination 4 4
Loss of or Failure to Bond 3 3
Appropriate Term/Code Not Available 3 3
No Pacing 3 3
Device Sensing Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 2 2
Communication or Transmission Problem 2 2
Inappropriate or Unexpected Reset 2 2
Failure to Charge 2 2
Arcing of Electrodes 2 2
Unexpected Shutdown 2 2
Unable to Obtain Readings 2 2
Noise, Audible 2 2
Failure to Deliver Shock/Stimulation 2 2
Inadequate User Interface 1 1
Low Audible Alarm 1 1
Failure to Align 1 1
Overheating of Device 1 1
Break 1 1
Insufficient Information 1 1
Loose or Intermittent Connection 1 1
Device Alarm System 1 1
Low Battery 1 1
Firing Problem 1 1
Failure to Analyze Signal 1 1
Protective Measures Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Fragmentation 1 1
Failure to Power Up 1 1
Pacing Intermittently 1 1
Incomplete or Inadequate Connection 1 1
Alarm Not Visible 1 1
Electrical Shorting 1 1
Signal Artifact/Noise 1 1
Capturing Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Activation Problem 1 1
Smoking 1 1
Device Dislodged or Dislocated 1 1
Output above Specifications 1 1
Output below Specifications 1 1
Intermittent Continuity 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Self-Activation or Keying 1 1
Programming Issue 1 1
Fire 1 1
Failure to Sense 1 1
Inaccurate Synchronization 1 1
Fracture 1 1
Product Quality Problem 1 1
Failure To Adhere Or Bond 1 1
Material Integrity Problem 1 1
Improper Device Output 1 1
Improper or Incorrect Procedure or Method 1 1
Battery Problem 1 1
Energy Output Problem 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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