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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 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Use of Device Problem 10 10
Appropriate Term/Code Not Available 10 10
Crack 4 4
Insufficient Information 3 3
Device Operates Differently Than Expected 3 3
Sparking 2 2
Pressure Problem 2 2
Patient-Device Incompatibility 2 2
Failure to Power Up 2 2
Inadequate or Insufficient Training 2 2
Circuit Failure 1 1
Material Split, Cut or Torn 1 1
Fire 1 1
Output Problem 1 1
Accessory Incompatible 1 1
Smoking 1 1
Defective Device 1 1
Contamination 1 1
Air Leak 1 1
Occlusion Within Device 1 1
Flare or Flash 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Misconnection 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Protective Measures Problem 1 1
Nonstandard Device 1 1
Device Inoperable 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Pneumothorax 11 11
Low Oxygen Saturation 9 9
No Known Impact Or Consequence To Patient 6 6
Cardiac Arrest 4 4
Cyanosis 3 3
Insufficient Information 3 3
Dyspnea 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Non specific EKG/ECG Changes 2 2
Death 2 2
Hemoptysis 2 2
Atrial Fibrillation 2 2
Pleural Effusion 2 2
Increased Respiratory Rate 2 2
Unspecified Infection 1 1
High Blood Pressure/ Hypertension 1 1
Pulmonary Emphysema 1 1
Bone Fracture(s) 1 1
Scarring 1 1
Burn(s) 1 1
Injury 1 1
Chest Pain 1 1
Vomiting 1 1
Pain 1 1
Laceration(s) 1 1
Pneumonia 1 1
Bradycardia 1 1
Pulmonary Edema 1 1
Convulsion/Seizure 1 1
Unspecified Respiratory Problem 1 1
No Consequences Or Impact To Patient 1 1
Bacterial Infection 1 1
Respiratory Failure 1 1
Bronchitis 1 1
Aspiration Pneumonitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jul-17-2024
2 Baxter Healthcare Corporation I May-30-2022
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