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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 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 57 57
Leak/Splash 50 50
Adverse Event Without Identified Device or Use Problem 41 41
Device Fell 37 37
Fire 35 35
Fluid/Blood Leak 34 34
Insufficient Information 24 24
Mechanical Jam 22 22
Use of Device Problem 21 21
Device Handling Problem 21 21
Smoking 21 21
Improper or Incorrect Procedure or Method 16 16
Device Dislodged or Dislocated 12 12
Problem with Software Installation 11 11
Contamination /Decontamination Problem 11 11
Failure to Disinfect 11 11
Chemical Problem 10 10
Sharp Edges 8 8
Overheating of Device 8 8
Sparking 8 8
Break 7 7
Device Emits Odor 6 6
Installation-Related Problem 6 6
Unintended Electrical Shock 6 6
No Apparent Adverse Event 5 5
Failure to Pump 5 5
Unintended System Motion 5 5
Failure to Clean Adequately 4 4
Failure to Align 3 3
Mechanical Problem 3 3
Crack 3 3
Pumping Problem 3 3
Corroded 3 3
Fracture 2 2
Computer Software Problem 2 2
Misassembled 2 2
Suction Failure 2 2
Material Split, Cut or Torn 2 2
Misassembled During Installation 2 2
No Flow 2 2
Difficult to Open or Close 2 2
Residue After Decontamination 2 2
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Infusion or Flow Problem 1 1
Misassembly During Maintenance/Repair 1 1
Insufficient Flow or Under Infusion 1 1
Shipping Damage or Problem 1 1
Material Twisted/Bent 1 1
Device Tipped Over 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 183 183
No Known Impact Or Consequence To Patient 54 54
No Consequences Or Impact To Patient 49 49
Injury 34 34
Laceration(s) 29 29
Insufficient Information 27 27
Bruise/Contusion 21 21
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
Superficial (First Degree) Burn 3 3
Unspecified Musculoskeletal problem 3 3
Burn, Thermal 3 3
No Patient Involvement 3 3
Electric Shock 2 2
Skin Irritation 2 2
Irritation 2 2
Burn(s) 2 2
Loss of Range of Motion 2 2
Patient Problem/Medical Problem 1 1
Damage to Ligament(s) 1 1
No Code Available 1 1
Hematoma 1 1
Inflammation 1 1
Crushing Injury 1 1
Contusion 1 1
Concussion 1 1
Ecchymosis 1 1
Partial thickness (Second Degree) Burn 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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