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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
63
63
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Alarm System
129
129
No Audible Alarm
13
13
Defective Alarm
7
7
Use of Device Problem
3
3
Temperature Problem
2
2
Application Program Problem
2
2
Wireless Communication Problem
2
2
Defective Device
2
2
Communication or Transmission Problem
2
2
Activation Problem
2
2
Adverse Event Without Identified Device or Use Problem
1
1
False Alarm
1
1
Device Difficult to Program or Calibrate
1
1
Product Quality Problem
1
1
Protective Measures Problem
1
1
Lack of Maintenance Documentation or Guidelines
1
1
Overheating of Device
1
1
Inadequate User Interface
1
1
Application Program Version or Upgrade Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Defective Component
1
1
Human-Device Interface Problem
1
1
Unexpected Shutdown
1
1
Activation, Positioning or Separation Problem
1
1
Output Problem
1
1
Break
1
1
Misassembled During Installation
1
1
Alarm Not Visible
1
1
Delayed Alarm
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
151
151
Insufficient Information
6
6
Fall
5
5
No Known Impact Or Consequence To Patient
3
3
Superficial (First Degree) Burn
2
2
Death
1
1
Fatigue
1
1
Head Injury
1
1
Abrasion
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
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