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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
Product CodeNHJ
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
ABMRC LLC
  SUBSTANTIALLY EQUIVALENT 3
DIMA ITALIA SRL
  SUBSTANTIALLY EQUIVALENT 2
HILL-ROM SERVICES PTE LTD
  SUBSTANTIALLY EQUIVALENT 4
LUNG ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEOIL PACIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 2 2
2017 6 6
2018 2 2
2019 1 1
2020 3 3
2021 5 5
2022 6 6
2023 17 17
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Appropriate Term/Code Not Available 10 10
Use of Device Problem 6 6
Device Operates Differently Than Expected 3 3
Crack 3 3
Failure to Power Up 2 2
Inadequate or Insufficient Training 2 2
Patient-Device Incompatibility 2 2
Device Inoperable 1 1
Material Split, Cut or Torn 1 1
Output Problem 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Smoking 1 1
Air Leak 1 1
Contamination 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Misconnection 1 1
Nonstandard Device 1 1
Occlusion Within Device 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Pneumothorax 8 8
No Known Impact Or Consequence To Patient 6 6
Low Oxygen Saturation 5 5
Insufficient Information 3 3
Dyspnea 3 3
Non specific EKG/ECG Changes 2 2
Cyanosis 2 2
Death 2 2
Atrial Fibrillation 2 2
Hemoptysis 2 2
Pleural Effusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Increased Respiratory Rate 2 2
Respiratory Failure 1 1
Convulsion/Seizure 1 1
Aspiration Pneumonitis 1 1
Unspecified Respiratory Problem 1 1
Pneumonia 1 1
Unspecified Infection 1 1
Scarring 1 1
Vomiting 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bronchitis 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Pulmonary Emphysema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I May-30-2022
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