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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bilirubin (total and unbound) in the neonate test system
Regulation Description Bilirubin (total and unbound) in the neonate test system.
Product CodeMQM
Regulation Number 862.1113
Device Class 1


Premarket Reviews
ManufacturerDecision
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 5 5
2019 6 6
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Patient Data Problem 2 2
Display Difficult to Read 1 1
No Display/Image 1 1
False Reading From Device Non-Compliance 1 1
Image Display Error/Artifact 1 1
Improper or Incorrect Procedure or Method 1 1
Low Test Results 1 1
High Readings 1 1
Low Readings 1 1
Output Problem 1 1
Programming Issue 1 1
Function Indicator Light 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Jaundice 2 2
Brain Injury 1 1
Test Result 1 1
No Information 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Neuropathy 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical Systems, Inc. I Jun-07-2018
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