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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, communication, powered
Regulation Description Powered communication system.
Product CodeILQ
Regulation Number 890.3710
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 27 29
2023 74 74
2024 105 105
2025 248 248
2026 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 497 497
No Audible Alarm 13 13
Defective Alarm 6 6
Alarm Not Visible 2 2
Material Split, Cut or Torn 2 2
Temperature Problem 2 2
Activation Problem 2 2
False Alarm 1 1
Output Problem 1 1
Delayed Alarm 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Self-Activation or Keying 1 1
Unintended Movement 1 1
Failure to Sense 1 1
Audible Prompt/Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 528 530
Fall 7 7
Insufficient Information 6 6
Abrasion 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Superficial (First Degree) Burn 2 2
Head Injury 2 2
Stroke/CVA 1 1
Hematoma 1 1
Laceration(s) 1 1
Cardiac Arrest 1 1
Bone Fracture(s) 1 1
Altered State of Consciousness 1 1
Hemorrhagic Stroke 1 1
Fatigue 1 1
Hip Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jun-30-2022
2 Baxter Healthcare Corporation II May-13-2022
3 Forbes Rehab Services Inc II Dec-28-2021
4 Hill-Rom Inc. II Dec-20-2021
5 Medminder Systems, Inc. II Jun-09-2022
6 Tobii Dynavox Llc II Apr-18-2023
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