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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
Product CodeILQ
Regulation Number 890.3710
Device Class 2


Premarket Reviews
ManufacturerDecision
IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 12 12
2016 4 4
2017 7 7
2018 7 7
2019 2 2
2020 2 2
2021 5 5
2022 27 27
2023 74 74
2024 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 96 96
No Audible Alarm 17 17
Defective Alarm 6 6
Use of Device Problem 6 6
Communication or Transmission Problem 6 6
Device Operates Differently Than Expected 6 6
Device Displays Incorrect Message 3 3
Application Program Problem 2 2
Device Inoperable 2 2
Defective Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Temperature Problem 2 2
Computer Software Problem 2 2
Insufficient Information 2 2
Wireless Communication Problem 2 2
Activation Problem 2 2
Activation, Positioning or Separation Problem 2 2
Misassembled During Installation 1 1
Unexpected Shutdown 1 1
Activation Failure 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Overheating of Device 1 1
Device Difficult to Setup or Prepare 1 1
Device Difficult to Program or Calibrate 1 1
Product Quality Problem 1 1
Material Separation 1 1
Device Stops Intermittently 1 1
Delayed Alarm 1 1
False Alarm 1 1
Alarm Not Visible 1 1
Failure To Adhere Or Bond 1 1
Premature Discharge of Battery 1 1
Break 1 1
Therapeutic or Diagnostic Output Failure 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1
Installation-Related Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Application Program Version or Upgrade Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 111 111
No Known Impact Or Consequence To Patient 11 11
Fall 9 9
Insufficient Information 6 6
No Information 5 5
Death 5 5
Cardiac Arrest 2 2
Stroke/CVA 2 2
Head Injury 2 2
No Code Available 2 2
No Consequences Or Impact To Patient 2 2
Complaint, Ill-Defined 1 1
Loss of consciousness 1 1
Superficial (First Degree) Burn 1 1
Bone Fracture(s) 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1
Therapeutic Effects, Unexpected 1 1
Burning Sensation 1 1
Abrasion 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 Dynavox Systems Llc II Apr-03-2018
4 Forbes Rehab Services Inc II Dec-28-2021
5 Hill-Rom Inc. II Dec-20-2021
6 Lifeline Systems Company II Apr-06-2018
7 Lifeline Systems, Incorporated II Oct-01-2015
8 Lifeline Systems, Incorporated II Jul-06-2015
9 Medminder Systems, Inc. II Jun-09-2022
10 Philips Lifeline Inc II Nov-25-2009
11 Rauland-Borg Corp II Sep-17-2013
12 Stanley Security Solutions Inc II Mar-20-2017
13 Tobii Assistive Technology, Inc. II Feb-01-2013
14 Tobii Assistive Technology, Inc. II Jun-29-2011
15 Tobii Dynavox Llc II Apr-18-2023
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