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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device regulator, vacuum
Product CodeKDP
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2014 18 18
2015 13 13
2016 18 18
2017 5 5
2018 1 1
2019 3 3
2022 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 15 15
Break 13 13
Material Integrity Problem 13 13
Suction Problem 7 7
Unstable 4 4
Torn Material 4 4
Device Inoperable 4 4
Leak/Splash 3 3
Crack 2 2
Defective Device 2 2
Failure to Cycle 2 2
Noise, Audible 2 2
Device Slipped 1 1
Increase in Suction 1 1
Sparking 1 1
Mechanical Problem 1 1
Insufficient Information 1 1
Contamination 1 1
Inadequate Instructions for Healthcare Professional 1 1
Failure to Power Up 1 1
Use of Incorrect Control/Treatment Settings 1 1
Calibration Problem 1 1
Device Handling Problem 1 1
Incorrect Measurement 1 1
Material Separation 1 1
Appropriate Term/Code Not Available 1 1
Component Incompatible 1 1
Self-Activation or Keying 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 26 26
No Patient Involvement 22 22
No Information 5 5
Respiratory Arrest 2 2
No Consequences Or Impact To Patient 2 2
Death 1 1
Nausea 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Vomiting 1 1
Insufficient Information 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ohio Medical Corporation II Jul-10-2018
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