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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
2014 92 92
2015 82 82
2016 80 80
2017 97 97
2018 73 73
2019 78 78
2020 80 80
2021 92 92
2022 85 85
2023 79 79
2024 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 146 146
Leak/Splash 127 127
Adverse Event Without Identified Device or Use Problem 68 68
Detachment of Device or Device Component 57 57
Fire 53 53
Device Fell 39 39
Insufficient Information 37 37
Device Operates Differently Than Expected 35 35
Smoking 32 32
Use of Device Problem 28 28
Improper or Incorrect Procedure or Method 28 28
Component Falling 27 27
Mechanical Jam 25 25
Device Handling Problem 22 22
Device Emits Odor 20 20
Device Displays Incorrect Message 18 18
Break 16 16
Overheating of Device 14 14
Device Dislodged or Dislocated 14 14
Contamination /Decontamination Problem 13 13
Failure to Disinfect 11 11
Sparking 11 11
Problem with Software Installation 11 11
Chemical Problem 10 10
Difficult to Open or Close 9 9
Residue After Decontamination 8 8
Sharp Edges 8 8
Installation-Related Problem 7 7
Unintended System Motion 7 7
Failure to Pump 7 7
Scratched Material 7 7
Device Issue 7 7
Unintended Electrical Shock 6 6
Detachment Of Device Component 6 6
Sticking 5 5
No Apparent Adverse Event 5 5
Device Reprocessing Problem 5 5
Device Inoperable 5 5
Failure to Clean Adequately 4 4
Defective Device 4 4
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 4 4
Crack 4 4
Difficult to Remove 4 4
Failure to Align 4 4
Obstruction of Flow 4 4
Mechanical Problem 4 4
Loss of Power 3 3
Loose or Intermittent Connection 3 3
Corroded 3 3
Device Slipped 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 290 290
No Clinical Signs, Symptoms or Conditions 183 183
No Consequences Or Impact To Patient 103 103
Injury 91 91
Laceration(s) 37 37
No Patient Involvement 34 34
Bruise/Contusion 28 28
Insufficient Information 27 27
Fall 22 22
No Information 14 14
Pain 10 10
Abrasion 10 10
Skin Tears 8 8
No Code Available 8 8
Burn, Thermal 7 7
Bone Fracture(s) 6 6
Burn(s) 5 5
Muscle/Tendon Damage 5 5
Superficial (First Degree) Burn 5 5
Unspecified Tissue Injury 4 4
Swelling 3 3
Unspecified Musculoskeletal problem 3 3
Inflammation 2 2
Irritation 2 2
Loss of Range of Motion 2 2
Skin Irritation 2 2
Electric Shock 2 2
Partial thickness (Second Degree) Burn 2 2
Crushing Injury 1 1
Contusion 1 1
Hematoma 1 1
Exposure to Body Fluids 1 1
Concussion 1 1
Ecchymosis 1 1
Sprain 1 1
Eye Injury 1 1
Physical Entrapment 1 1
Tissue Damage 1 1
Patient Problem/Medical Problem 1 1
Damage to Ligament(s) 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Getinge Disinfection II Oct-17-2013
2 Getinge Disinfection Ab II Apr-16-2018
3 Getinge Disinfection Ab III Aug-25-2015
4 Getinge Disinfection Ab II Dec-23-2014
5 Getinge Group Logistics America, LLC II Feb-16-2021
6 Getinge USA Inc II Jul-26-2012
7 Getinge Usa Sales Inc II Jun-08-2022
8 Getinge Usa Sales Inc II May-13-2022
9 Maquet Cardiovascular Us Sales, Llc III Feb-27-2020
10 Maquet Cardiovascular Us Sales, Llc II Feb-18-2020
11 Maquet Cardiovascular Us Sales, Llc II Jun-13-2019
12 Natus Medical Incorporated II Jun-02-2017
13 Steris Corporation II May-17-2023
14 Steris Corporation II Jun-09-2022
15 Steris Corporation II Jan-15-2021
16 Steris Corporation II Mar-09-2019
17 Steris Corporation II Jul-09-2018
18 Steris Corporation III Jul-10-2014
19 Steris Corporation II Aug-01-2012
20 Steris Corporation II Sep-01-2011
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