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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 3
BREAS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM SERVICES PTE LTD
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 3 3
2021 5 5
2022 6 6
2023 17 17
2024 40 40
2025 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30 30
Crack 12 12
Use of Device Problem 10 10
Appropriate Term/Code Not Available 10 10
Insufficient Information 5 5
Sparking 3 3
Material Split, Cut or Torn 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
Failure to Power Up 2 2
Gas/Air Leak 2 2
Improper Chemical Reaction 2 2
Improper or Incorrect Procedure or Method 2 2
Disconnection 1 1
Fire 1 1
Output Problem 1 1
Incomplete or Inadequate Connection 1 1
Accessory Incompatible 1 1
Flare or Flash 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 34 34
Low Oxygen Saturation 19 19
Pneumothorax 13 13
Cardiac Arrest 6 6
Cyanosis 4 4
Bacterial Infection 4 4
Insufficient Information 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
Atrial Fibrillation 2 2
Pleural Effusion 2 2
Dyspnea 2 2
Aspiration Pneumonitis 2 2
High Blood Pressure/ Hypertension 1 1
Death 1 1
Pulmonary Dysfunction 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 Jul-17-2024
2 Baxter Healthcare Corporation I May-30-2022
3 Percussionaire Corporation I Oct-30-2024
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