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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
system, environmental control, powered
Product Code
IQA
Regulation Number
890.3725
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
1
1
2016
1
1
2017
1
1
2018
1
1
2020
1
1
2022
2
2
2023
18
26
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Key or Button Unresponsive/not Working
14
22
Defective Alarm
2
2
Labelling, Instructions for Use or Training Problem
2
2
Activation Failure
2
2
Low Battery
1
1
Operating System Becomes Nonfunctional
1
1
Device Alarm System
1
1
Device Fell
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Loss of Data
1
1
Noise, Audible
1
1
Smoking
1
1
Device Operates Differently Than Expected
1
1
Use of Device Problem
1
1
Computer Operating System Problem
1
1
Failure of Device to Self-Test
1
1
Device Inoperable
1
1
Device Stops Intermittently
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
21
29
No Known Impact Or Consequence To Patient
4
4
Head Injury
2
2
Death
1
1
No Information
1
1
Fall
1
1
Ecchymosis
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ascom (US) Inc.
II
Nov-20-2018
2
Intel-GE Care Innovations LLC
II
May-24-2013
3
Intel-GE Care Innovations LLC
III
Jun-05-2012
4
Intel-GE Care Innovations LLC
III
May-16-2012
5
Securitas Healthcare LLC
II
Jul-23-2024
6
Securitas Healthcare LLC
II
Jul-23-2024
7
Securitas Healthcare LLC
II
May-31-2024
8
Securitas Healthcare LLC
II
Nov-03-2023
9
Securitas Healthcare LLC
II
Mar-14-2023
10
Stanley Security Solutions Inc
II
Jan-14-2022
11
Stanley Security Solutions Inc
II
Jul-19-2019
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