TPLC - Total Product Life Cycle

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Device	system, communication, powered
Regulation Description	Powered communication system.
Product Code	ILQ
Regulation Number	890.3710
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Alarm System	403	403
No Audible Alarm	15	15
Defective Alarm	9	9
Therapeutic or Diagnostic Output Failure	5	5
Product Quality Problem	4	4
Application Program Problem	3	3
Material Split, Cut or Torn	2	2
Communication or Transmission Problem	2	2
Activation Problem	2	2
Wireless Communication Problem	2	4
Alarm Not Visible	2	2
Use of Device Problem	2	2
Self-Activation or Keying	2	2
Temperature Problem	2	2
Activation, Positioning or Separation Problem	1	1
Unexpected Shutdown	1	1
Break	1	1
Output Problem	1	1
Application Program Version or Upgrade Problem	1	1
Unintended Movement	1	1
Failure to Sense	1	1
Defective Device	1	1
Misassembled During Installation	1	1
Delayed Alarm	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Audible Prompt/Feedback Problem	1	1
False Alarm	1	1
Device Difficult to Program or Calibrate	1	1
Protective Measures Problem	1	1
Human-Device Interface Problem	1	1
Overheating of Device	1	1
Lack of Maintenance Documentation or Guidelines	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	432	434
Fall	7	7
Insufficient Information	6	6
Superficial (First Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Head Injury	2	2
Abrasion	2	2
Stroke/CVA	1	1
Hip Fracture	1	1
Fatigue	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Hemorrhagic Stroke	1	1
Cardiac Arrest	1	1
Laceration(s)	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