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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 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 145 145
Leak/Splash 124 124
Adverse Event Without Identified Device or Use Problem 67 67
Fire 53 53
Detachment of Device or Device Component 48 48
Insufficient Information 36 36
Device Fell 36 36
Device Operates Differently Than Expected 35 35
Smoking 30 30
Improper or Incorrect Procedure or Method 28 28
Component Falling 27 27
Mechanical Jam 25 25
Device Handling Problem 22 22
Use of Device Problem 22 22
Device Emits Odor 20 20
Device Displays Incorrect Message 18 18
Break 16 16
Device Dislodged or Dislocated 14 14
Contamination /Decontamination Problem 13 13
Overheating of Device 13 13
Sparking 11 11
Failure to Disinfect 11 11
Problem with Software Installation 11 11
Chemical Problem 10 10
Difficult to Open or Close 9 9
Sharp Edges 8 8
Residue After Decontamination 8 8
Device Issue 7 7
Unintended System Motion 7 7
Failure to Pump 7 7
Scratched Material 7 7
Installation-Related Problem 7 7
Unintended Electrical Shock 6 6
Detachment Of Device Component 6 6
Device Reprocessing Problem 5 5
Sticking 5 5
Device Inoperable 5 5
No Apparent Adverse Event 5 5
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 4 4
Defective Device 4 4
Difficult to Remove 4 4
Obstruction of Flow 4 4
Failure to Align 4 4
Crack 4 4
Mechanical Problem 4 4
Loose or Intermittent Connection 3 3
Corroded 3 3
Defective Component 3 3
Device Slipped 3 3
Loss of Power 3 3
Pumping Problem 3 3
No Flow 2 2
Device Sensing Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Integrity Problem 2 2
Device Tipped Over 2 2
Device Contamination with Chemical or Other Material 2 2
Human Factors Issue 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Suction Failure 2 2
Failure to Clean Adequately 2 2
Misassembled During Installation 2 2
Disconnection 2 2
Inadequate or Insufficient Training 2 2
Fumes or Vapors 2 2
Computer Software Problem 2 2
No Display/Image 2 2
Burst Container or Vessel 2 2
Device Alarm System 2 2
Melted 2 2
Misassembled 2 2
Entrapment of Device 2 2
Filling Problem 2 2
Fracture 2 2
Material Fragmentation 2 2
Material Frayed 1 1
Grounding Malfunction 1 1
Flaked 1 1
Moisture Damage 1 1
Unintended Collision 1 1
Bent 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Air Leak 1 1
Electrical /Electronic Property Problem 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Material Discolored 1 1
Split 1 1
Failure to Advance 1 1
Malposition of Device 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Component Missing 1 1
Overfill 1 1
Metal Shedding Debris 1 1
Insufficient Flow or Under Infusion 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Self-Activation or Keying 1 1

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 165 165
No Consequences Or Impact To Patient 103 103
Injury 91 91
No Patient Involvement 34 34
Laceration(s) 34 34
Insufficient Information 26 26
Bruise/Contusion 24 24
Fall 21 21
No Information 14 14
Abrasion 10 10
Pain 9 9
No Code Available 8 8
Skin Tears 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
Unspecified Musculoskeletal problem 3 3
Swelling 3 3
Electric Shock 2 2
Partial thickness (Second Degree) Burn 2 2
Loss of Range of Motion 2 2
Skin Irritation 2 2
Inflammation 2 2
Irritation 2 2
Damage to Ligament(s) 1 1
Sprain 1 1
Contusion 1 1
Crushing Injury 1 1
Ecchymosis 1 1
Eye Injury 1 1
Hematoma 1 1
Exposure to Body Fluids 1 1
Device Embedded In Tissue or Plaque 1 1
Patient Problem/Medical Problem 1 1
Tissue Damage 1 1
Concussion 1 1
Physical Entrapment 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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