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TPLC
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Device
nebulizer (direct patient interface)
Regulation Description
Nebulizer.
Product Code
CAF
Regulation Number
868.5630
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADHERIUM (NZ) LTD
SUBSTANTIALLY EQUIVALENT
4
AEROGEN LTD.
SUBSTANTIALLY EQUIVALENT
1
AIREHEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
BREATHESUITE INC
SUBSTANTIALLY EQUIVALENT
1
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD.
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
MANKIND PHARMA LIMITED
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTIRES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES LP
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, LP
SUBSTANTIALLY EQUIVALENT
1
MONAGHAN MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OCHSNER CLINIC FOUNDATION
SUBSTANTIALLY EQUIVALENT
1
PARI RESPIRATORY EQUIPMENT, INC.
SUBSTANTIALLY EQUIVALENT
2
RECIPROCAL LABS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN HOMED MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN IVANKACA TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
THAYER MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
THE RITEDOSE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TRUDELL MEDICAL INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
2
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
117
117
2021
161
161
2022
55
55
2023
107
107
2024
102
103
2025
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Deliver
105
105
Break
33
33
Connection Problem
30
30
Mechanical Problem
22
22
Leak/Splash
17
17
Disconnection
17
17
Use of Device Problem
17
17
Insufficient Information
15
15
Defective Device
15
15
Failure to Infuse
14
14
Adverse Event Without Identified Device or Use Problem
14
14
Improper Flow or Infusion
13
13
Fire
12
12
Output Problem
12
12
Infusion or Flow Problem
11
11
Therapeutic or Diagnostic Output Failure
11
11
Patient Device Interaction Problem
11
11
Melted
10
10
Fluid/Blood Leak
10
10
Smoking
8
8
Detachment of Device or Device Component
8
8
Failure to Power Up
7
7
Appropriate Term/Code Not Available
7
7
Defective Component
6
6
Insufficient Flow or Under Infusion
6
7
Unexpected Shutdown
6
6
Overheating of Device
6
6
Gas/Air Leak
6
6
Electrical /Electronic Property Problem
6
6
Loose or Intermittent Connection
6
6
Contamination
5
5
No Flow
5
5
Component Missing
5
5
Incorrect, Inadequate or Imprecise Result or Readings
5
5
Sparking
4
4
Temperature Problem
4
4
Product Quality Problem
4
4
Degraded
4
4
Material Integrity Problem
4
4
Unexpected Therapeutic Results
4
4
Thermal Decomposition of Device
3
3
Pressure Problem
3
3
Inaccurate Delivery
3
3
Partial Blockage
3
3
Device Displays Incorrect Message
3
3
Obstruction of Flow
3
3
Material Rupture
3
3
Protective Measures Problem
2
2
Separation Problem
2
2
Incomplete or Inadequate Connection
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
300
301
Insufficient Information
76
76
No Consequences Or Impact To Patient
52
52
No Known Impact Or Consequence To Patient
23
23
Low Oxygen Saturation
14
14
No Patient Involvement
14
14
Dyspnea
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Unspecified Respiratory Problem
7
7
Aspiration/Inhalation
5
5
Unintended Extubation
5
5
Respiratory Insufficiency
4
4
Swelling/ Edema
4
4
Dizziness
3
3
Arrhythmia
3
3
Asthma
3
3
Increased Respiratory Rate
3
3
Cyanosis
3
3
Headache
3
3
No Information
3
3
Pneumothorax
2
2
Pneumonia
2
2
Itching Sensation
2
2
High Pulmonary Arterial Wedge Pressure
2
2
Sore Throat
2
2
Urinary Frequency
2
2
Pulmonary Hypertension
2
2
Cough
2
2
Fibrosis
2
2
Bronchospasm
2
2
Unspecified Infection
2
2
Hypoxia
2
2
Hypersensitivity/Allergic reaction
2
2
Chest Pain
2
2
Burn(s)
2
2
Bacterial Infection
2
2
Apnea
2
2
Airway Obstruction
2
2
Partial thickness (Second Degree) Burn
1
1
Heart Failure/Congestive Heart Failure
1
1
Missed Dose
1
1
Respiratory Arrest
1
1
Skin Inflammation/ Irritation
1
1
Wheezing
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Ulcer
1
1
Malaise
1
1
Low Blood Pressure/ Hypotension
1
1
Fatigue
1
1
Decreased Respiratory Rate
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
I
Sep-14-2023
2
Smiths Medical ASD Inc.
II
Apr-29-2021
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