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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
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
Detachment of Device or Device Component
57
57
Leak/Splash
50
50
Adverse Event Without Identified Device or Use Problem
41
41
Device Fell
37
37
Fire
35
35
Fluid/Blood Leak
34
34
Insufficient Information
24
24
Mechanical Jam
22
22
Smoking
21
21
Use of Device Problem
21
21
Device Handling Problem
21
21
Improper or Incorrect Procedure or Method
16
16
Device Dislodged or Dislocated
12
12
Failure to Disinfect
11
11
Problem with Software Installation
11
11
Contamination /Decontamination Problem
11
11
Chemical Problem
10
10
Sparking
8
8
Overheating of Device
8
8
Sharp Edges
8
8
Break
7
7
Unintended Electrical Shock
6
6
Installation-Related Problem
6
6
Device Emits Odor
6
6
Unintended System Motion
5
5
Failure to Pump
5
5
No Apparent Adverse Event
5
5
Failure to Clean Adequately
4
4
Corroded
3
3
Failure to Align
3
3
Pumping Problem
3
3
Crack
3
3
Mechanical Problem
3
3
Misassembled
2
2
Residue After Decontamination
2
2
Misassembled During Installation
2
2
Computer Software Problem
2
2
Suction Failure
2
2
No Flow
2
2
Fracture
2
2
Difficult to Open or Close
2
2
Material Split, Cut or Torn
2
2
Infusion or Flow Problem
1
1
Insufficient Flow or Under Infusion
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Difficult to Remove
1
1
Misassembly During Maintenance/Repair
1
1
Positioning Problem
1
1
Defective Component
1
1
Defective Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
183
183
No Known Impact Or Consequence To Patient
54
54
No Consequences Or Impact To Patient
49
49
Injury
34
34
Laceration(s)
29
29
Insufficient Information
27
27
Bruise/Contusion
21
21
Fall
14
14
Abrasion
10
10
Pain
10
10
Skin Tears
8
8
Bone Fracture(s)
6
6
Muscle/Tendon Damage
5
5
Unspecified Tissue Injury
4
4
Superficial (First Degree) Burn
3
3
Unspecified Musculoskeletal problem
3
3
Burn, Thermal
3
3
No Patient Involvement
3
3
Electric Shock
2
2
Skin Irritation
2
2
Irritation
2
2
Burn(s)
2
2
Loss of Range of Motion
2
2
Patient Problem/Medical Problem
1
1
Damage to Ligament(s)
1
1
No Code Available
1
1
Hematoma
1
1
Inflammation
1
1
Crushing Injury
1
1
Contusion
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
Maquet Cardiovascular Us Sales, Llc
II
Jun-13-2019
7
Steris Corporation
II
May-17-2023
8
Steris Corporation
II
Jun-09-2022
9
Steris Corporation
II
Jan-15-2021
10
Steris Corporation
II
Mar-09-2019
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