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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
2020 80 80
2021 92 92
2022 85 85
2023 79 79
2024 78 78
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 52 52
Leak/Splash 43 43
Device Fell 38 38
Adverse Event Without Identified Device or Use Problem 28 28
Fluid/Blood Leak 27 27
Insufficient Information 27 27
Fire 26 26
Use of Device Problem 24 24
Mechanical Jam 21 21
Smoking 18 18
Improper or Incorrect Procedure or Method 17 17
Device Handling Problem 17 17
Problem with Software Installation 11 11
Failure to Disinfect 10 10
Contamination /Decontamination Problem 10 10
Device Dislodged or Dislocated 9 9
Sharp Edges 8 8
Sparking 7 7
Chemical Problem 7 7
Mechanical Problem 6 6
Overheating of Device 6 6
Unintended Electrical Shock 6 6
No Apparent Adverse Event 6 6
Installation-Related Problem 6 6
Break 5 5
Unintended System Motion 5 5
Failure to Pump 5 5
Pumping Problem 3 3
Failure to Clean Adequately 3 3
Device Emits Odor 3 3
Failure to Align 3 3
No Flow 2 2
Corroded 2 2
Difficult to Open or Close 2 2
Fracture 2 2
Residue After Decontamination 2 2
Misassembled 2 2
Infusion or Flow Problem 2 2
Misassembled During Installation 2 2
Unintended Movement 2 2
Suction Failure 2 2
Crack 2 2
Device Alarm System 2 2
Material Split, Cut or Torn 2 2
Insufficient Flow or Under Infusion 1 1
Device Difficult to Maintain 1 1
Material Twisted/Bent 1 1
Misassembly During Maintenance/Repair 1 1
Shipping Damage or Problem 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 199
Insufficient Information 31 31
Laceration(s) 30 30
No Known Impact Or Consequence To Patient 22 22
No Consequences Or Impact To Patient 22 22
Bruise/Contusion 22 22
Pain 18 18
Injury 16 16
Fall 11 11
Abrasion 10 10
Muscle/Tendon Damage 10 10
Skin Tears 8 8
Bone Fracture(s) 6 6
Unspecified Tissue Injury 4 4
Superficial (First Degree) Burn 3 3
Unspecified Musculoskeletal problem 3 3
Burn(s) 3 3
Electric Shock 2 2
Skin Irritation 2 2
Loss of Range of Motion 2 2
No Patient Involvement 2 2
Damage to Ligament(s) 1 1
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Hematoma 1 1
Inflammation 1 1
Crushing Injury 1 1
Burn, Thermal 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 Steris Corporation II May-17-2023
7 Steris Corporation II Jun-09-2022
8 Steris Corporation II Jan-15-2021
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