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TPLC
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show TPLC since
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Device
table, obstetrical, ac-powered (and accessories)
Product Code
HDD
Regulation Number
884.4900
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
151
151
2015
40
40
2016
1
1
2017
4
4
2018
18
18
2019
14
28
2020
17
36
2021
19
37
2022
14
63
2023
19
59
2024
4
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Slipped
69
69
Break
62
62
Mechanical Problem
32
50
Unintended System Motion
23
28
Positioning Failure
20
113
Sticking
15
15
Sharp Edges
13
20
Unintended Movement
12
12
Bent
12
12
Device Operates Differently Than Expected
11
11
Device Fell
11
16
Component Missing
9
9
Self-Activation or Keying
9
9
Unintended Head Motion
9
9
Loose or Intermittent Connection
8
8
Electrical /Electronic Property Problem
8
16
Component Falling
8
8
Positioning Problem
8
19
Device Inoperable
7
7
Collapse
5
5
Detachment Of Device Component
5
5
Naturally Worn
5
5
Scratched Material
4
4
Device Alarm System
3
3
Difficult To Position
2
2
Corroded
2
2
Failure to Align
2
2
Malposition of Device
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Material Integrity Problem
2
2
Defective Component
2
2
Mechanics Altered
1
1
Insufficient Information
1
1
Connection Problem
1
1
Device Damaged by Another Device
1
1
Device Dislodged or Dislocated
1
1
Defective Device
1
1
Device Tipped Over
1
1
Sparking
1
1
Overheating of Device
1
1
Unstable
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Loss of Power
1
1
Failure to Power Up
1
1
Decrease in Pressure
1
1
Migration or Expulsion of Device
1
1
Device Emits Odor
1
1
Use of Incorrect Control/Treatment Settings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
170
170
No Clinical Signs, Symptoms or Conditions
58
177
No Consequences Or Impact To Patient
35
35
No Patient Involvement
24
52
Injury
6
6
Fall
3
3
Insufficient Information
3
3
Pain
2
2
Tissue Damage
1
1
Laceration(s)
1
1
Nerve Damage
1
1
Numbness
1
1
Complaint, Ill-Defined
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hill-Rom, Inc.
II
Dec-17-2009
2
Linet Americas
III
Aug-12-2020
3
Linet Spol. S.r.o.
II
Mar-09-2019
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