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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
2017 97 97
2018 73 73
2019 78 78
2020 80 80
2021 92 92
2022 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 79 79
Leak/Splash 57 57
Adverse Event Without Identified Device or Use Problem 53 53
Fire 40 40
Detachment of Device or Device Component 37 37
Insufficient Information 26 26
Smoking 19 19
Mechanical Jam 17 17
Device Fell 17 17
Improper or Incorrect Procedure or Method 16 16
Device Handling Problem 15 15
Component Falling 14 14
Overheating of Device 13 13
Contamination /Decontamination Problem 12 12
Device Emits Odor 11 11
Use of Device Problem 11 11
Problem with Software Installation 11 11
Break 10 10
Chemical Problem 10 10
Device Operates Differently Than Expected 9 9
Failure to Disinfect 9 9
Device Dislodged or Dislocated 8 8
Device Issue 7 7
Failure to Pump 7 7
Sparking 6 6
Scratched Material 6 6
Difficult to Open or Close 5 5
Device Displays Incorrect Message 4 4
Defective Device 4 4
Residue After Decontamination 4 4
Difficult to Remove 4 4
Unintended System Motion 4 4
Device Reprocessing Problem 4 4
Crack 4 4
Obstruction of Flow 3 3
Failure to Align 3 3
No Apparent Adverse Event 3 3
Unintended Electrical Shock 3 3
Sharp Edges 3 3
Suction Failure 2 2
Failure to Clean Adequately 2 2
Misassembled During Installation 2 2
Pumping Problem 2 2
Misassembled 2 2
Computer Software Problem 2 2
Corroded 2 2
Fracture 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Melted 1 1
Off-Label Use 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Metal Shedding Debris 1 1
Sticking 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Material Fragmentation 1 1
Grounding Malfunction 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Flaked 1 1
Device Alarm System 1 1
Detachment Of Device Component 1 1
Circuit Failure 1 1
Insufficient Flow or Under Infusion 1 1
Defective Component 1 1
Fumes or Vapors 1 1
Split 1 1
Device Tipped Over 1 1
Overfill 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Human Factors Issue 1 1
Inadequate User Interface 1 1
Infusion or Flow Problem 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Device Sensing Problem 1 1
No Flow 1 1
Component or Accessory Incompatibility 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 132 132
No Clinical Signs, Symptoms or Conditions 92 92
No Consequences Or Impact To Patient 65 65
Injury 65 65
No Patient Involvement 29 29
Laceration(s) 23 23
Insufficient Information 21 21
Fall 15 15
No Information 11 11
Bruise/Contusion 9 9
Burn, Thermal 7 7
Skin Tears 6 6
Bone Fracture(s) 5 5
Abrasion 5 5
Superficial (First Degree) Burn 4 4
Unspecified Tissue Injury 4 4
No Code Available 3 3
Muscle/Tendon Damage 3 3
Pain 3 3
Skin Irritation 2 2
Electric Shock 2 2
Irritation 2 2
Unspecified Musculoskeletal problem 2 2
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1
Hematoma 1 1
Burn(s) 1 1
Contusion 1 1
Crushing Injury 1 1
Ecchymosis 1 1
Tissue Damage 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 Getinge Usa Sales Inc II Jun-08-2022
4 Getinge Usa Sales Inc II May-13-2022
5 Maquet Cardiovascular Us Sales, Llc III Feb-27-2020
6 Maquet Cardiovascular Us Sales, Llc II Feb-18-2020
7 Maquet Cardiovascular Us Sales, Llc II Jun-13-2019
8 Natus Medical Incorporated II Jun-02-2017
9 Steris Corporation II Jun-09-2022
10 Steris Corporation II Jan-15-2021
11 Steris Corporation II Mar-09-2019
12 Steris Corporation II Jul-09-2018
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