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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, environmental control, powered
Product CodeIQA
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
Labelling, Instructions for Use or Training Problem 2 2
Activation Failure 2 2
Defective Alarm 2 2
Low Battery 1 1
Operating System Becomes Nonfunctional 1 1
Device Fell 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure of Device to Self-Test 1 1
Loss of Data 1 1
Device Alarm System 1 1
Smoking 1 1
Computer Operating System Problem 1 1
Device Operates Differently Than Expected 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Noise, Audible 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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