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TPLC
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Device
nebulizer (direct patient interface)
Product Code
CAF
Regulation Number
868.5630
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADHERIUM (NZ) LTD
SUBSTANTIALLY EQUIVALENT
9
AIREHEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
BREATHESUITE INC
SUBSTANTIALLY EQUIVALENT
1
COGNITA LABS, LLC
SUBSTANTIALLY EQUIVALENT
1
EXCELLENTCARE MEDICAL (HUIZHOU) LTD.
SUBSTANTIALLY EQUIVALENT
1
FEELLIFE HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HCMED INNOVATIONS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTIRES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
MICROBASE TECHNOLOGY CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MONAGHAN MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OCHSNER CLINIC FOUNDATION
SUBSTANTIALLY EQUIVALENT
1
PARI RESPIRATORY EQUIPMENT, INC.
SUBSTANTIALLY EQUIVALENT
2
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
RECIPROCAL LABS CORPORATION
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
THE RITEDOSE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TRUDELL MEDICAL INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
4
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
162
162
2019
185
185
2020
117
117
2021
161
161
2022
55
55
2023
70
70
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Deliver
185
185
Connection Problem
70
70
Leak/Splash
62
62
Disconnection
46
46
Break
40
40
Fluid/Blood Leak
23
23
Fitting Problem
22
22
Defective Device
19
19
Mechanical Problem
17
17
Electrical /Electronic Property Problem
16
16
Use of Device Problem
15
15
Improper Flow or Infusion
15
15
Gas/Air Leak
14
14
Output Problem
14
14
Material Rupture
14
14
No Flow
13
13
Therapeutic or Diagnostic Output Failure
13
13
Insufficient Information
12
12
Patient Device Interaction Problem
11
11
Detachment of Device or Device Component
11
11
Fire
11
11
Defective Component
10
10
Infusion or Flow Problem
10
10
Adverse Event Without Identified Device or Use Problem
8
8
Appropriate Term/Code Not Available
7
7
Degraded
7
7
Loose or Intermittent Connection
6
6
Inaccurate Delivery
6
6
Obstruction of Flow
6
6
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Improper or Incorrect Procedure or Method
5
5
Sparking
5
5
Device Operates Differently Than Expected
4
4
Smoking
4
4
Component Missing
4
4
Melted
4
4
Overheating of Device
4
4
Product Quality Problem
4
4
Contamination
4
4
Display or Visual Feedback Problem
3
3
Off-Label Use
3
3
Failure to Power Up
3
3
Device Displays Incorrect Message
3
3
Charging Problem
3
3
Noise, Audible
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Integrity Problem
2
2
Electrical Shorting
2
2
Device Emits Odor
2
2
Device Contamination with Chemical or Other Material
2
2
No Pressure
2
2
Packaging Problem
2
2
Pressure Problem
2
2
Protective Measures Problem
2
2
Temperature Problem
2
2
Complete Loss of Power
2
2
Unexpected Shutdown
2
2
Separation Problem
2
2
Material Split, Cut or Torn
2
2
Malposition of Device
2
2
Incomplete or Missing Packaging
2
2
Insufficient Flow or Under Infusion
2
2
Thermal Decomposition of Device
2
2
Burst Container or Vessel
2
2
Detachment Of Device Component
2
2
Component Falling
1
1
Component Incompatible
1
1
Device Alarm System
1
1
No Audible Alarm
1
1
Failure to Charge
1
1
Corroded
1
1
Material Disintegration
1
1
Device Difficult to Setup or Prepare
1
1
Decrease in Pressure
1
1
Material Puncture/Hole
1
1
Difficult to Remove
1
1
Nonstandard Device
1
1
Incorrect Measurement
1
1
Fracture
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Labelling, Instructions for Use or Training Problem
1
1
Unexpected Therapeutic Results
1
1
Unstable
1
1
Material Too Rigid or Stiff
1
1
Material Separation
1
1
Inappropriate Audible Prompt/Feedback
1
1
Device Damaged Prior to Use
1
1
Difficult or Delayed Activation
1
1
Patient-Device Incompatibility
1
1
Battery Problem
1
1
Chemical Problem
1
1
Contamination /Decontamination Problem
1
1
Communication or Transmission Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Device-Device Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Failure to Eject
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
231
231
No Clinical Signs, Symptoms or Conditions
199
199
No Known Impact Or Consequence To Patient
93
93
No Patient Involvement
80
80
Insufficient Information
52
52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
No Information
8
8
Low Oxygen Saturation
8
8
Dyspnea
7
7
Respiratory Distress
6
6
Unspecified Respiratory Problem
6
6
Unintended Extubation
5
5
Aspiration/Inhalation
5
5
Asthma
3
3
Apnea
3
3
Dizziness
3
3
No Code Available
3
3
Bronchospasm
3
3
Swelling/ Edema
2
2
Fibrosis
2
2
Cough
2
2
Death
2
2
Urinary Frequency
2
2
Sore Throat
2
2
Unspecified Infection
2
2
Itching Sensation
2
2
Pneumonia
2
2
Arrhythmia
2
2
Airway Obstruction
2
2
Headache
2
2
Bacterial Infection
2
2
Bradycardia
2
2
Burn(s)
2
2
Cardiopulmonary Arrest
2
2
Chest Pain
1
1
Cyanosis
1
1
Hemorrhage/Bleeding
1
1
Low Blood Pressure/ Hypotension
1
1
Fatigue
1
1
Abrasion
1
1
Pneumothorax
1
1
Pulmonary Edema
1
1
Rash
1
1
Laceration(s)
1
1
Occlusion
1
1
Peeling
1
1
Ulcer
1
1
Right Ventricular Dysfunction
1
1
Burning Sensation
1
1
Pulmonary Hypertension
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Superficial (First Degree) Burn
1
1
Patient Problem/Medical Problem
1
1
Increased Respiratory Rate
1
1
Sleep Dysfunction
1
1
Eye Burn
1
1
Burn, Thermal
1
1
Underdose
1
1
Electric Shock
1
1
Missed Dose
1
1
Chemical Exposure
1
1
Heart Failure/Congestive Heart Failure
1
1
Skin Inflammation/ Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
I
Sep-14-2023
2
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
I
Feb-04-2019
3
SANRAI INTERNATIONAL LLC
II
Mar-26-2019
4
Smiths Medical ASD Inc.
II
Apr-29-2021
5
Valeant Pharmacueticals International
II
Jan-17-2018
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