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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 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 53 53
Leak/Splash 49 49
Adverse Event Without Identified Device or Use Problem 40 40
Fire 35 35
Device Fell 35 35
Fluid/Blood Leak 34 34
Insufficient Information 24 24
Mechanical Jam 22 22
Device Handling Problem 21 21
Smoking 21 21
Use of Device Problem 18 18
Improper or Incorrect Procedure or Method 16 16
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
Break 7 7
Overheating of Device 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 Clean Adequately 4 4
Failure to Align 3 3
Mechanical Problem 3 3
Corroded 3 3
Crack 3 3
Pumping Problem 3 3
No Flow 2 2
Material Split, Cut or Torn 2 2
Difficult to Open or Close 2 2
Computer Software Problem 2 2
Fracture 2 2
Misassembled 2 2
Residue After Decontamination 2 2
Misassembled During Installation 2 2
Suction Failure 2 2
Complete Loss of Power 1 1
Misassembly During Maintenance/Repair 1 1
Inadequate or Insufficient Training 1 1
Fumes or Vapors 1 1
Defective Device 1 1
Device Tipped Over 1 1
Device Displays Incorrect Message 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Insufficient Flow or Under Infusion 1 1
Defective Component 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
Component or Accessory Incompatibility 1 1
Failure to Shut Off 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Sensing Problem 1 1
Difficult to Advance 1 1
Physical Resistance/Sticking 1 1
Positioning Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 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 176 176
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 20 20
Fall 14 14
Abrasion 10 10
Pain 10 10
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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