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TPLC
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Device
disinfector, medical devices
Product Code
MEC
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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