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TPLC
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Device
device, positive pressure breathing, intermittent
Product Code
NHJ
Regulation Number
868.5905
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABMRC LLC
SUBSTANTIALLY EQUIVALENT
3
DIMA ITALIA SRL
SUBSTANTIALLY EQUIVALENT
2
HILL-ROM SERVICES PTE LTD
SUBSTANTIALLY EQUIVALENT
4
1. K124032
METANEB
2. K151689
MetaNeb 4 System
3. K192143
Maximus System
4. K200988
Maximus System
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
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
13
13
Appropriate Term/Code Not Available
10
10
Use of Device Problem
6
6
Device Operates Differently Than Expected
3
3
Crack
3
3
Failure to Power Up
2
2
Inadequate or Insufficient Training
2
2
Patient-Device Incompatibility
2
2
Fire
1
1
Sparking
1
1
Gas/Air Leak
1
1
Infusion or Flow Problem
1
1
Contamination
1
1
Misconnection
1
1
Improper or Incorrect Procedure or Method
1
1
Flare or Flash
1
1
Device Inoperable
1
1
Smoking
1
1
Material Split, Cut or Torn
1
1
Occlusion Within Device
1
1
Electrical /Electronic Property Problem
1
1
Air Leak
1
1
Protective Measures Problem
1
1
Pressure Problem
1
1
Electrical Shorting
1
1
Device Contamination with Chemical or Other Material
1
1
Display or Visual Feedback Problem
1
1
Improper Flow or Infusion
1
1
Output Problem
1
1
Nonstandard Device
1
1
Defective Device
1
1
Insufficient Information
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13
13
Pneumothorax
8
8
No Known Impact Or Consequence To Patient
6
6
Low Oxygen Saturation
5
5
Dyspnea
3
3
Insufficient Information
3
3
Atrial Fibrillation
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Increased Respiratory Rate
2
2
Non specific EKG/ECG Changes
2
2
Pleural Effusion
2
2
Cyanosis
2
2
Hemoptysis
2
2
Death
2
2
Bradycardia
1
1
Pulmonary Emphysema
1
1
Burn(s)
1
1
Convulsion/Seizure
1
1
Unspecified Respiratory Problem
1
1
No Consequences Or Impact To Patient
1
1
Bacterial Infection
1
1
Bronchitis
1
1
Respiratory Failure
1
1
Scarring
1
1
Vomiting
1
1
Unspecified Infection
1
1
Injury
1
1
Chest Pain
1
1
Cardiac Arrest
1
1
Pneumonia
1
1
Aspiration Pneumonitis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
I
May-30-2022
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