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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device refrigerator, freezer, blood storage
Product CodeKSE
Regulation Number 864.9700
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Excessive Cooling 1 1
Nonstandard Device 1 1
Improper or Incorrect Procedure or Method 1 1
Device Alarm System 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Environmental Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1

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