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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 77 77
Leak/Splash 55 55
Adverse Event Without Identified Device or Use Problem 50 50
Detachment of Device or Device Component 36 36
Fire 35 35
Insufficient Information 25 25
Smoking 19 19
Improper or Incorrect Procedure or Method 15 15
Component Falling 14 14
Overheating of Device 13 13
Device Handling Problem 13 13
Device Fell 12 12
Contamination /Decontamination Problem 12 12
Mechanical Jam 12 12
Device Emits Odor 11 11
Chemical Problem 10 10
Break 9 9
Device Operates Differently Than Expected 9 9
Failure to Disinfect 8 8
Use of Device Problem 8 8
Failure to Pump 7 7
Device Issue 7 7
Scratched Material 6 6
Sparking 5 5
Difficult to Open or Close 5 5
Device Dislodged or Dislocated 4 4
Defective Device 4 4
Device Displays Incorrect Message 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
Unintended Electrical Shock 3 3
Sharp Edges 2 2
Failure to Clean Adequately 2 2
Misassembled During Installation 2 2
Misassembled 2 2
Pumping Problem 2 2
Computer Software Problem 2 2
Corroded 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Melted 1 1
Off-Label Use 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Metal Shedding Debris 1 1
Sticking 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Device Alarm System 1 1
Detachment Of Device Component 1 1
Circuit Failure 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Flaked 1 1
Fracture 1 1
Material Fragmentation 1 1
Grounding Malfunction 1 1
No Flow 1 1
Device Sensing Problem 1 1
Device Ingredient or Reagent Problem 1 1
Device Markings/Labelling 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
Insufficient Flow or Under Infusion 1 1
Fumes or Vapors 1 1
Split 1 1
Overfill 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Component or Accessory Incompatibility 1 1
Suction Failure 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
No Apparent Adverse Event 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 132 132
No Consequences Or Impact To Patient 65 65
Injury 65 65
No Clinical Signs, Symptoms or Conditions 61 61
No Patient Involvement 29 29
Laceration(s) 20 20
Insufficient Information 17 17
Fall 14 14
No Information 11 11
Bruise/Contusion 7 7
Burn, Thermal 7 7
Skin Tears 5 5
Abrasion 5 5
Bone Fracture(s) 4 4
Superficial (First Degree) Burn 4 4
Unspecified Tissue Injury 4 4
No Code Available 3 3
Electric Shock 2 2
Skin Irritation 2 2
Irritation 2 2
Pain 1 1
Hematoma 1 1
Contusion 1 1
Ecchymosis 1 1
Tissue Damage 1 1
Patient Problem/Medical Problem 1 1
Muscle/Tendon Damage 1 1
Unspecified Musculoskeletal problem 1 1
Device Embedded In Tissue or Plaque 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 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 Natus Medical Incorporated II Jun-02-2017
8 Steris Corporation II Jan-15-2021
9 Steris Corporation II Mar-09-2019
10 Steris Corporation II Jul-09-2018
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