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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device conserver, oxygen
Regulation Description Noncontinuous ventilator (IPPB).
Product CodeNFB
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 4 4
2017 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Burst Container or Vessel 2 2
Gas Leak 2 2
No Flow 2 2
Fire 1 1
Inaccurate Delivery 1 1
Device Operates Differently Than Expected 1 1
Valve(s) 1 1
Defective Component 1 1
Flare or Flash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Injury 2 2
No Code Available 1 1
Death 1 1
Overdose 1 1
Abrasion 1 1
Burn(s) 1 1
Fainting 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Inovo, Inc II Jul-29-2019
2 Invacare Corporation II Aug-08-2016
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