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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device combination compression/decompression manual chest pump with impedance respiratory valve
Definition Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.
Product CodePIZ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 2 0 0 0 0 0 1 0 1 0

MDR Year MDR Reports MDR Events
2015 1 1
2016 2 2
2017 10 10
2018 5 5
2019 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 9 9
Misassembled 8 8
Calibration Problem 6 6
Detachment of Device or Device Component 5 5
Detachment Of Device Component 4 4
Mechanical Problem 4 4
Improper or Incorrect Procedure or Method 1 1
Device Operational Issue 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
Pneumothorax 1 1
Skin Tears 1 1
No Patient Involvement 1 1

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