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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
ABMRC, LLC
  SUBSTANTIALLY EQUIVALENT 2
BREAS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 6 6
2023 17 17
2024 40 40
2025 35 35
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 33 33
Crack 24 24
Use of Device Problem 10 10
Appropriate Term/Code Not Available 10 10
Insufficient Information 6 6
Sparking 4 4
Improper Flow or Infusion 3 3
Failure to Power Up 3 3
Material Split, Cut or Torn 3 3
Improper Chemical Reaction 2 2
Pressure Problem 2 2
Circuit Failure 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 2 2
Patient-Device Incompatibility 2 2
Electrical Shorting 1 1
Flare or Flash 1 1
Gas/Air Leak 1 1
Infusion or Flow Problem 1 1
Accessory Incompatible 1 1
Smoking 1 1
Inadequate or Insufficient Training 1 1
Disconnection 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Misconnection 1 1
Temperature Problem 1 1
Output Problem 1 1
Device Handling Problem 1 1
Excessive Heating 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 48 48
Low Oxygen Saturation 20 20
Pneumothorax 12 12
Cardiac Arrest 6 6
Cyanosis 4 4
Bacterial Infection 4 4
Atrial Fibrillation 3 3
Insufficient Information 3 3
Pneumonia 3 3
Increased Respiratory Rate 3 3
Non specific EKG/ECG Changes 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hemoptysis 2 2
Pleural Effusion 2 2
Dyspnea 2 2
Aspiration Pneumonitis 2 2
High Blood Pressure/ Hypertension 1 1
Pulmonary Dysfunction 1 1
Bronchial Hemorrhage 1 1
Dizziness 1 1
Bone Fracture(s) 1 1
Unspecified Nervous System Problem 1 1
Vomiting 1 1
Discomfort 1 1
Respiratory Tract Infection 1 1
Laceration(s) 1 1
Pain 1 1
Choking 1 1
Bradycardia 1 1
Pulmonary Edema 1 1
Tachycardia 1 1
Swelling/ Edema 1 1
Convulsion/Seizure 1 1
Unspecified Respiratory Problem 1 1
Headache 1 1
Deformity/ Disfigurement 1 1
Glossitis 1 1
Respiratory Failure 1 1
Bronchitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Apr-01-2026
2 Baxter Healthcare Corporation I Jul-17-2024
3 Baxter Healthcare Corporation I May-30-2022
4 Percussionaire Corporation I Oct-30-2024
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