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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
  1.  K213564  BiWaze Clear System
  2.  K231728  BiWaze Clear System
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 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 35 35
Crack 27 27
Use of Device Problem 10 10
Appropriate Term/Code Not Available 10 10
Insufficient Information 6 6
Sparking 4 4
Material Split, Cut or Torn 3 3
Failure to Power Up 3 3
Improper Flow or Infusion 3 3
Circuit Failure 2 2
Pressure Problem 2 2
Patient-Device Incompatibility 2 2
Defective Component 2 2
Improper Chemical Reaction 2 2
Improper or Incorrect Procedure or Method 2 2
Disconnection 1 1
No Display/Image 1 1
Fire 1 1
Output Problem 1 1
Incomplete or Inadequate Connection 1 1
Accessory Incompatible 1 1
Smoking 1 1
Flare or Flash 1 1
Gas/Air Leak 1 1
Infusion or Flow Problem 1 1
Misconnection 1 1
Device Handling Problem 1 1
Electrical Shorting 1 1
Excessive Heating 1 1
Inadequate or Insufficient Training 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 51 51
Low Oxygen Saturation 21 21
Pneumothorax 12 12
Cardiac Arrest 7 7
Cyanosis 5 5
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
Respiratory Tract Infection 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
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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