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Device
disinfector, medical devices
Regulation Description
Medical washer-disinfector.
Product Code
MEC
Regulation Number
880.6992
Device Class
2
MDR Year
MDR Reports
MDR Events
2016
80
80
2017
97
97
2018
73
73
2019
78
78
2020
80
80
2021
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid Leak
87
87
Leak/Splash
56
56
Adverse Event Without Identified Device or Use Problem
49
49
Fire
29
29
Smoking
18
18
Device Operates Differently Than Expected
18
18
Component Falling
18
18
Device Emits Odor
16
16
Device Component Or Accessory
16
16
Detachment of Device or Device Component
13
13
Improper or Incorrect Procedure or Method
12
12
Device Displays Incorrect Message
12
12
Contamination /Decontamination Problem
11
11
Device Handling Problem
11
11
Insufficient Information
10
10
Overheating of Device
9
9
Break
9
9
Chemical Problem
9
9
Use of Device Problem
8
8
Device Issue
7
7
Washer
7
7
Mechanical Jam
7
7
Scratched Material
7
7
Device Fell
6
6
Difficult to Open or Close
5
5
Defective Device
4
4
Sparking
4
4
Failure to Align
4
4
Device Reprocessing Problem
4
4
Difficult to Remove
4
4
Detachment Of Device Component
4
4
Residue After Decontamination
3
3
Loose or Intermittent Connection
3
3
Crack
3
3
Failure to Disinfect
3
3
Failure to Pump
3
3
Obstruction of Flow
3
3
Device Dislodged or Dislocated
3
3
Material Fragmentation
2
2
Inadequate or Insufficient Training
2
2
Human Factors Issue
2
2
Pumping Problem
2
2
Misassembled
2
2
Computer Software Problem
2
2
Corroded
2
2
Defective Component
2
2
Device Inoperable
2
2
Unintended System Motion
2
2
Device Sensing Problem
2
2
Material Integrity Problem
2
2
Moisture or Humidity Problem
1
1
Failure to Clean Adequately
1
1
Unintended Movement
1
1
Device Subassembly
1
1
Unit
1
1
Switch, Push Button
1
1
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Device Contamination with Chemical or Other Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Device Ingredient or Reagent Problem
1
1
Device Markings/Labelling Problem
1
1
Malposition of Device
1
1
Self-Activation or Keying
1
1
Sticking
1
1
Insufficient Flow or Under Infusion
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Disconnection
1
1
Electrical /Electronic Property Problem
1
1
Entrapment of Device
1
1
Flaked
1
1
Material Frayed
1
1
Moisture Damage
1
1
Unintended Collision
1
1
Gasket
1
1
Device Alarm System
1
1
Thermal Decomposition of Device
1
1
Circuit Failure
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Inadequate User Interface
1
1
Infusion or Flow Problem
1
1
Installation-Related Problem
1
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Material Protrusion/Extrusion
1
1
Operating System Becomes Nonfunctional
1
1
Wheel
1
1
Misassembly by Users
1
1
Appropriate Term/Code Not Available
1
1
Noise, Audible
1
1
Misassembled During Installation
1
1
Incorrect, Inadequate or Imprecise Resultor Readings
1
1
Device Slipped
1
1
Failure to Power Up
1
1
Off-Label Use
1
1
Mechanical Problem
1
1
Clamp
1
1
Failure to Auto Stop
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
179
179
No Consequences Or Impact To Patient
72
72
Injury
72
72
No Patient Involvement
32
32
Laceration(s)
12
12
Fall
12
12
No Information
11
11
No Clinical Signs, Symptoms or Conditions
10
10
Burn, Thermal
7
7
Bruise/Contusion
5
5
No Code Available
5
5
Superficial (First Degree) Burn
3
3
Irritation
2
2
Skin Irritation
2
2
Swelling
2
2
Abrasion
2
2
Bone Fracture(s)
2
2
Contusion
1
1
Eye Injury
1
1
Pain
1
1
Tissue Damage
1
1
Patient Problem/Medical Problem
1
1
Device Embedded In Tissue or Plaque
1
1
Burn(s)
1
1
Hematoma
1
1
Insufficient Information
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
Maquet Cardiovascular Us Sales, Llc
III
Feb-27-2020
4
Maquet Cardiovascular Us Sales, Llc
II
Feb-18-2020
5
Maquet Cardiovascular Us Sales, Llc
II
Jun-13-2019
6
Natus Medical Incorporated
II
Jun-02-2017
7
Steris Corporation
II
Jan-15-2021
8
Steris Corporation
II
Mar-09-2019
9
Steris Corporation
II
Jul-09-2018
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