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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, positive pressure breathing, intermittent
Regulation Description Noncontinuous ventilator (IPPB).
Product CodeNHJ
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
HILL-ROM SERVICES PTE LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 2 2
2017 6 6
2018 2 2
2019 1 1
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Device Operates Differently Than Expected 2 2
Gas Leak 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Air Leak 1 1
Nonstandard Device 1 1
Failure to Power Up 1 1
Smoking 1 1
Use of Device Problem 1 1
Defective Device 1 1
Unit 1 1
Power Cord 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
Pneumothorax 2 2
Scarring 1 1
Injury 1 1
Death 1 1
Pneumonia 1 1
Burn(s) 1 1
Pulmonary Emphysema 1 1
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1

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