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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device software, transmission and storage, patient data
Definition Non-alarming software that captures patient data from patient monitoring devices and transmits the data to the patient electronic medical record, where the data is stored.
Product CodeNSX
Device Class Unclassified

MDR Year MDR Reports MDR Events
2018 1 1
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Data Problem 2 2
Application Program Problem: Medication Error 2 2
Computer Software Problem 1 1
Device Inoperable 1 1
Improper or Incorrect Procedure or Method 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Convulsion/Seizure 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merge Healthcare, Inc. II Oct-23-2020
2 bioMerieux, Inc. II Aug-26-2022
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