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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bath, incubators/water, all
Product CodeJTQ
Regulation Number 866.2540
Device Class 1

MDR Year MDR Reports MDR Events
2015 4 4
2016 1 1
2019 2 2
2020 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Intermittent Loss of Power 3 3
Device Operates Differently Than Expected 2 2
Appropriate Term/Code Not Available 1 1
Break 1 1
Contamination 1 1
Mechanical Problem 1 1
Poor Quality Image 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 1 1
No Patient Involvement 1 1
Burn(s) 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Thermo Fisher Scientific (Asheville) LLC II Jun-21-2019
2 Thermo Fisher Scientific (Asheville) LLC II Apr-10-2013
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