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TPLC
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show TPLC since
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2024
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Device
system, communication, powered
Product Code
ILQ
Regulation Number
890.3710
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
2
2
2020
2
2
2021
5
5
2022
27
27
2023
74
74
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Alarm System
79
79
No Audible Alarm
13
13
Defective Alarm
5
5
Use of Device Problem
3
3
Defective Device
2
2
Application Program Problem
2
2
Temperature Problem
2
2
Wireless Communication Problem
2
2
Activation Problem
2
2
Communication or Transmission Problem
2
2
Activation, Positioning or Separation Problem
1
1
Human-Device Interface Problem
1
1
Inadequate User Interface
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Protective Measures Problem
1
1
Delayed Alarm
1
1
False Alarm
1
1
Alarm Not Visible
1
1
Break
1
1
Overheating of Device
1
1
Device Difficult to Program or Calibrate
1
1
Product Quality Problem
1
1
Misassembled During Installation
1
1
Unexpected Shutdown
1
1
Therapeutic or Diagnostic Output Failure
1
1
Application Program Version or Upgrade Problem
1
1
Defective Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
101
101
Insufficient Information
6
6
Fall
4
4
No Known Impact Or Consequence To Patient
3
3
Laceration(s)
1
1
Superficial (First Degree) Burn
1
1
Abrasion
1
1
Cardiac Arrest
1
1
Death
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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