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TPLC
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show TPLC since
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Device
disinfector, medical devices
Product Code
MEC
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
53
53
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
146
146
Leak/Splash
127
127
Adverse Event Without Identified Device or Use Problem
68
68
Detachment of Device or Device Component
57
57
Fire
53
53
Device Fell
39
39
Insufficient Information
37
37
Device Operates Differently Than Expected
35
35
Smoking
32
32
Improper or Incorrect Procedure or Method
28
28
Use of Device Problem
28
28
Component Falling
27
27
Mechanical Jam
25
25
Device Handling Problem
22
22
Device Emits Odor
20
20
Device Displays Incorrect Message
18
18
Break
16
16
Overheating of Device
14
14
Device Dislodged or Dislocated
14
14
Contamination /Decontamination Problem
13
13
Failure to Disinfect
11
11
Sparking
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
Installation-Related Problem
7
7
Failure to Pump
7
7
Scratched Material
7
7
Device Issue
7
7
Unintended System Motion
7
7
Detachment Of Device Component
6
6
Unintended Electrical Shock
6
6
No Apparent Adverse Event
5
5
Sticking
5
5
Device Reprocessing Problem
5
5
Device Inoperable
5
5
Defective Device
4
4
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
4
4
Failure to Clean Adequately
4
4
Crack
4
4
Mechanical Problem
4
4
Failure to Align
4
4
Obstruction of Flow
4
4
Difficult to Remove
4
4
Corroded
3
3
Loose or Intermittent Connection
3
3
Defective Component
3
3
Loss of Power
3
3
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
183
183
No Consequences Or Impact To Patient
103
103
Injury
91
91
Laceration(s)
37
37
No Patient Involvement
34
34
Bruise/Contusion
28
28
Insufficient Information
27
27
Fall
22
22
No Information
14
14
Abrasion
10
10
Pain
10
10
No Code Available
8
8
Skin Tears
8
8
Burn, Thermal
7
7
Bone Fracture(s)
6
6
Superficial (First Degree) Burn
5
5
Burn(s)
5
5
Muscle/Tendon Damage
5
5
Unspecified Tissue Injury
4
4
Unspecified Musculoskeletal problem
3
3
Swelling
3
3
Electric Shock
2
2
Skin Irritation
2
2
Inflammation
2
2
Partial thickness (Second Degree) Burn
2
2
Irritation
2
2
Loss of Range of Motion
2
2
Device Embedded In Tissue or Plaque
1
1
Tissue Damage
1
1
Eye Injury
1
1
Physical Entrapment
1
1
Ecchymosis
1
1
Concussion
1
1
Exposure to Body Fluids
1
1
Contusion
1
1
Crushing Injury
1
1
Hematoma
1
1
Sprain
1
1
Damage to Ligament(s)
1
1
Patient Problem/Medical Problem
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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