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TPLC
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show TPLC since
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2024
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Device
table, obstetric (and accessories)
Product Code
KNC
Regulation Number
884.4900
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
15
15
2017
2
2
2018
37
37
2019
60
60
2020
44
44
2021
25
25
2022
25
25
2023
45
45
2024
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
94
94
Device Slipped
84
84
Loose or Intermittent Connection
22
22
Material Split, Cut or Torn
21
21
Unintended System Motion
14
14
Defective Component
11
11
Self-Activation or Keying
10
10
Device Alarm System
6
6
Device Operates Differently Than Expected
5
5
Activation Problem
5
5
No Audible Alarm
4
4
Break
4
4
Disconnection
2
2
Mechanical Problem
2
2
Crack
2
2
Collapse
2
2
Component Falling
2
2
Intermittent Continuity
1
1
Leak/Splash
1
1
Defective Alarm
1
1
Device Dislodged or Dislocated
1
1
Device Inoperable
1
1
Device Stops Intermittently
1
1
Device Tipped Over
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Positioning Problem
1
1
Defective Device
1
1
Component Missing
1
1
Positioning Failure
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
121
121
No Clinical Signs, Symptoms or Conditions
113
113
No Known Impact Or Consequence To Patient
43
43
No Consequences Or Impact To Patient
11
11
Insufficient Information
2
2
Bruise/Contusion
2
2
Neck Pain
1
1
Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hill-Rom, Inc.
II
Jul-28-2021
2
Hill-Rom, Inc.
II
Sep-08-2016
3
Hill-Rom, Inc.
II
Sep-01-2014
4
Hill-Rom, Inc.
II
Jul-26-2012
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