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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
HILL-ROM SERVICES PTE LTD
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 3 3
2021 5 5
2022 6 6
2023 17 17
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12 12
Appropriate Term/Code Not Available 10 10
Use of Device Problem 7 7
Crack 3 3
Sparking 2 2
Patient-Device Incompatibility 2 2
Pressure Problem 2 2
Insufficient Information 1 1
Material Split, Cut or Torn 1 1
Improper or Incorrect Procedure or Method 1 1
Output Problem 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Misconnection 1 1
Failure to Power Up 1 1
Inadequate or Insufficient Training 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Pneumothorax 8 8
Low Oxygen Saturation 6 6
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cyanosis 2 2
Increased Respiratory Rate 2 2
Atrial Fibrillation 2 2
Dyspnea 2 2
Non specific EKG/ECG Changes 2 2
Hemoptysis 2 2
Pleural Effusion 2 2
Pneumonia 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bronchitis 1 1
Cardiac Arrest 1 1
Convulsion/Seizure 1 1
Aspiration Pneumonitis 1 1
Unspecified Respiratory Problem 1 1
Death 1 1
Vomiting 1 1
Respiratory Failure 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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