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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
2020 1 1
2022 2 2
2023 18 26

Device Problems MDRs with this Device Problem Events in those MDRs
Key or Button Unresponsive/not Working 14 22
Activation Failure 2 2
Defective Alarm 2 2
Smoking 1 1
Failure of Device to Self-Test 1 1
Operating System Becomes Nonfunctional 1 1
Noise, Audible 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 29

Recalls
Manufacturer Recall Class Date Posted
1 Securitas Healthcare LLC II Nov-03-2023
2 Securitas Healthcare LLC II Mar-14-2023
3 Stanley Security Solutions Inc II Jan-14-2022
4 Stanley Security Solutions Inc II Jul-19-2019
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