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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, powered
Product CodeINQ
Regulation Number 890.3760
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 6 6
2016 2 2
2017 4 4
2018 2 2
2019 3 3
2021 1 1
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Unintended Movement 2 2
Insufficient Information 2 2
Device Operates Differently Than Expected 2 2
Self-Activation or Keying 2 2
Improper or Incorrect Procedure or Method 2 2
Solder Joint Fracture 1 1
Patient-Device Incompatibility 1 1
Failure to Sense 1 1
Use of Device Problem 1 1
Mechanical Problem 1 1
Unintended System Motion 1 1
Unintended Arm Motion 1 1
Electrical /Electronic Property Problem 1 1
Device Operational Issue 1 1
Electrical Shorting 1 1
Material Integrity Problem 1 1
No Fail-Safe Mechanism 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bone Fracture(s) 6 6
No Consequences Or Impact To Patient 3 3
Physical Entrapment 3 3
No Known Impact Or Consequence To Patient 3 3
Injury 3 3
Pain 2 2
Sprain 1 1
Swelling 1 1
Vertigo 1 1
Discomfort 1 1
Contusion 1 1
Crushing Injury 1 1
No Patient Involvement 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Oct-11-2018
2 Phillips Nuclear Medicine II Jan-12-2011
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