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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
Regulation Description Medical washer-disinfector.
Product CodeMEC
Regulation Number 880.6992
Device Class 2

MDR Year MDR Reports MDR Events
2016 80 80
2017 97 97
2018 73 73
2019 78 78
2020 80 80
2021 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 87 87
Leak/Splash 56 56
Adverse Event Without Identified Device or Use Problem 49 49
Fire 29 29
Smoking 18 18
Device Operates Differently Than Expected 18 18
Component Falling 18 18
Device Emits Odor 16 16
Device Component Or Accessory 16 16
Detachment of Device or Device Component 13 13
Improper or Incorrect Procedure or Method 12 12
Device Displays Incorrect Message 12 12
Contamination /Decontamination Problem 11 11
Device Handling Problem 11 11
Insufficient Information 10 10
Overheating of Device 9 9
Break 9 9
Chemical Problem 9 9
Use of Device Problem 8 8
Device Issue 7 7
Washer 7 7
Mechanical Jam 7 7
Scratched Material 7 7
Device Fell 6 6
Difficult to Open or Close 5 5
Defective Device 4 4
Sparking 4 4
Failure to Align 4 4
Device Reprocessing Problem 4 4
Difficult to Remove 4 4
Detachment Of Device Component 4 4
Residue After Decontamination 3 3
Loose or Intermittent Connection 3 3
Crack 3 3
Failure to Disinfect 3 3
Failure to Pump 3 3
Obstruction of Flow 3 3
Device Dislodged or Dislocated 3 3
Material Fragmentation 2 2
Inadequate or Insufficient Training 2 2
Human Factors Issue 2 2
Pumping Problem 2 2
Misassembled 2 2
Computer Software Problem 2 2
Corroded 2 2
Defective Component 2 2
Device Inoperable 2 2
Unintended System Motion 2 2
Device Sensing Problem 2 2
Material Integrity Problem 2 2
Moisture or Humidity Problem 1 1
Failure to Clean Adequately 1 1
Unintended Movement 1 1
Device Subassembly 1 1
Unit 1 1
Switch, Push Button 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Malposition of Device 1 1
Self-Activation or Keying 1 1
Sticking 1 1
Insufficient Flow or Under Infusion 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Disconnection 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Flaked 1 1
Material Frayed 1 1
Moisture Damage 1 1
Unintended Collision 1 1
Gasket 1 1
Device Alarm System 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Protrusion/Extrusion 1 1
Operating System Becomes Nonfunctional 1 1
Wheel 1 1
Misassembly by Users 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Misassembled During Installation 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Device Slipped 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Mechanical Problem 1 1
Clamp 1 1
Failure to Auto Stop 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 179 179
No Consequences Or Impact To Patient 72 72
Injury 72 72
No Patient Involvement 32 32
Laceration(s) 12 12
Fall 12 12
No Information 11 11
No Clinical Signs, Symptoms or Conditions 10 10
Burn, Thermal 7 7
Bruise/Contusion 5 5
No Code Available 5 5
Superficial (First Degree) Burn 3 3
Irritation 2 2
Skin Irritation 2 2
Swelling 2 2
Abrasion 2 2
Bone Fracture(s) 2 2
Contusion 1 1
Eye Injury 1 1
Pain 1 1
Tissue Damage 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Burn(s) 1 1
Hematoma 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Getinge Disinfection Ab II Apr-16-2018
2 Getinge Group Logistics America, LLC II Feb-16-2021
3 Maquet Cardiovascular Us Sales, Llc III Feb-27-2020
4 Maquet Cardiovascular Us Sales, Llc II Feb-18-2020
5 Maquet Cardiovascular Us Sales, Llc II Jun-13-2019
6 Natus Medical Incorporated II Jun-02-2017
7 Steris Corporation II Jan-15-2021
8 Steris Corporation II Mar-09-2019
9 Steris Corporation II Jul-09-2018
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