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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device disinfector, medical devices
Product CodeMEC
Regulation Number 880.6992
Device Class 2

MDR Year MDR Reports MDR Events
2019 78 78
2020 80 80
2021 92 92
2022 85 85
2023 79 79
2024 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 48 48
Leak/Splash 47 47
Adverse Event Without Identified Device or Use Problem 40 40
Fire 35 35
Device Fell 34 34
Fluid/Blood Leak 33 33
Insufficient Information 23 23
Mechanical Jam 22 22
Device Handling Problem 21 21
Smoking 19 19
Improper or Incorrect Procedure or Method 16 16
Use of Device Problem 15 15
Device Dislodged or Dislocated 12 12
Contamination /Decontamination Problem 11 11
Problem with Software Installation 11 11
Failure to Disinfect 11 11
Chemical Problem 10 10
Sparking 8 8
Sharp Edges 8 8
Overheating of Device 7 7
Break 7 7
Device Emits Odor 6 6
Installation-Related Problem 6 6
Unintended Electrical Shock 6 6
No Apparent Adverse Event 5 5
Unintended System Motion 5 5
Failure to Pump 5 5
Failure to Align 3 3
Mechanical Problem 3 3
Corroded 3 3
Crack 3 3
Pumping Problem 3 3
No Flow 2 2
Difficult to Open or Close 2 2
Material Split, Cut or Torn 2 2
Residue After Decontamination 2 2
Computer Software Problem 2 2
Fracture 2 2
Misassembled 2 2
Suction Failure 2 2
Failure to Clean Adequately 2 2
Misassembled During Installation 2 2
Misassembly During Maintenance/Repair 1 1
Inadequate or Insufficient Training 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fumes or Vapors 1 1
Defective Device 1 1
Device Tipped Over 1 1
Device Displays Incorrect Message 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Grounding Malfunction 1 1
Flaked 1 1
Melted 1 1
Device Alarm System 1 1
Circuit Failure 1 1
Device Reprocessing Problem 1 1
Electrical /Electronic Property Problem 1 1
Filling Problem 1 1
Insufficient Flow or Under Infusion 1 1
Defective Component 1 1
Device Ingredient or Reagent Problem 1 1
Device Sensing Problem 1 1
Difficult to Advance 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Component or Accessory Incompatibility 1 1
Failure to Shut Off 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Physical Resistance/Sticking 1 1
Complete Loss of Power 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Device Difficult to Maintain 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 165 165
No Known Impact Or Consequence To Patient 54 54
No Consequences Or Impact To Patient 49 49
Injury 34 34
Insufficient Information 26 26
Laceration(s) 26 26
Bruise/Contusion 17 17
Fall 13 13
Abrasion 10 10
Pain 9 9
Skin Tears 8 8
Bone Fracture(s) 6 6
Muscle/Tendon Damage 5 5
Unspecified Tissue Injury 4 4
Unspecified Musculoskeletal problem 3 3
Burn, Thermal 3 3
No Patient Involvement 3 3
Superficial (First Degree) Burn 3 3
Electric Shock 2 2
Burn(s) 2 2
Loss of Range of Motion 2 2
Skin Irritation 2 2
Irritation 2 2
Damage to Ligament(s) 1 1
Concussion 1 1
Contusion 1 1
Crushing Injury 1 1
Ecchymosis 1 1
Hematoma 1 1
Inflammation 1 1
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Getinge Group Logistics America, LLC II Feb-16-2021
2 Getinge Usa Sales Inc II Jun-08-2022
3 Getinge Usa Sales Inc II May-13-2022
4 Maquet Cardiovascular Us Sales, Llc III Feb-27-2020
5 Maquet Cardiovascular Us Sales, Llc II Feb-18-2020
6 Maquet Cardiovascular Us Sales, Llc II Jun-13-2019
7 Steris Corporation II May-17-2023
8 Steris Corporation II Jun-09-2022
9 Steris Corporation II Jan-15-2021
10 Steris Corporation II Mar-09-2019
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