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TPLC
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Device
ventilator, continuous, non-life-supporting
Product Code
MNS
Regulation Number
868.5895
Device Class
2
Premarket Reviews
Manufacturer
Decision
BMC MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SMD MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
1
1. K231064
ReddyPort Elbow
MDR Year
MDR Reports
MDR Events
2019
275
275
2020
64
64
2021
254
254
2022
2499
2499
2023
1313
1313
2024
224
224
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
3805
3805
Corroded
233
233
Contamination
71
71
Nonstandard Device
46
46
Device Displays Incorrect Message
42
42
Battery Problem
39
39
Failure to Power Up
34
34
Electrical /Electronic Property Problem
34
34
Adverse Event Without Identified Device or Use Problem
30
30
Unexpected Shutdown
28
28
Power Problem
26
26
Output Problem
26
26
Pressure Problem
24
24
Device Alarm System
23
23
Patient-Device Incompatibility
20
20
Therapeutic or Diagnostic Output Failure
20
20
Insufficient Information
19
19
Circuit Failure
18
18
Protective Measures Problem
17
17
Increase in Pressure
15
15
Device Emits Odor
14
14
Defective Component
13
13
Defective Device
11
11
Failure to Charge
11
11
Noise, Audible
11
11
Material Integrity Problem
10
10
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Self-Activation or Keying
9
9
Display or Visual Feedback Problem
9
9
Failure to Calibrate
9
9
Mechanical Problem
9
9
Overheating of Device
7
7
Decrease in Pressure
7
7
Loss of Power
6
6
Break
6
6
Defective Alarm
6
6
Crack
6
6
Fire
5
5
Component Missing
5
5
Temperature Problem
5
5
Inadequate User Interface
4
4
Contamination /Decontamination Problem
4
4
Communication or Transmission Problem
4
4
Computer Operating System Problem
4
4
Calibration Problem
4
4
Patient Device Interaction Problem
4
4
Computer Software Problem
4
4
Thermal Decomposition of Device
3
3
No Audible Alarm
3
3
Unintended Power Up
3
3
Melted
3
3
No Display/Image
3
3
Failure to Run on Battery
3
3
Complete Loss of Power
3
3
Excessive Heating
3
3
Failure to Shut Off
3
3
Device Contamination with Chemical or Other Material
3
3
Device Sensing Problem
3
3
No Pressure
3
3
Improper Flow or Infusion
3
3
Detachment of Device or Device Component
2
2
Charging Problem
2
2
Electrical Shorting
2
2
Unintended Application Program Shut Down
2
2
Appropriate Term/Code Not Available
2
2
Failure to Sense
2
2
Smoking
2
2
Tidal Volume Fluctuations
2
2
Inaccurate Delivery
2
2
Leak/Splash
2
2
Loose or Intermittent Connection
2
2
Moisture Damage
2
2
Material Fragmentation
2
2
Intermittent Continuity
2
2
Material Disintegration
2
2
Display Difficult to Read
1
1
Insufficient Cooling
1
1
Insufficient Heating
1
1
Image Display Error/Artifact
1
1
Excess Flow or Over-Infusion
1
1
Poor Quality Image
1
1
Disconnection
1
1
Failure to Disinfect
1
1
Failure to Cycle
1
1
Decrease in Suction
1
1
Loss of or Failure to Bond
1
1
Dent in Material
1
1
Application Security Problem
1
1
Blocked Connection
1
1
Unstable
1
1
Use of Device Problem
1
1
Fitting Problem
1
1
Inaccurate Synchronization
1
1
Fungus in Device Environment
1
1
Material Separation
1
1
Product Quality Problem
1
1
Failure to Transmit Record
1
1
Premature End-of-Life Indicator
1
1
Pacing Problem
1
1
Particulates
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2656
2656
Dyspnea
553
553
Headache
370
370
Unspecified Respiratory Problem
294
294
Cough
237
237
Sore Throat
230
230
Respiratory Tract Infection
180
180
No Patient Involvement
176
176
Dizziness
152
152
Cancer
123
123
No Known Impact Or Consequence To Patient
77
77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
69
69
Dry Mouth
67
67
Insufficient Information
62
62
Nausea
58
58
Unspecified Heart Problem
57
57
No Consequences Or Impact To Patient
53
53
Chest Pain
47
47
Asthma
45
45
Sleep Dysfunction
40
40
Skin Inflammation/ Irritation
40
40
Epistaxis
35
35
Unspecified Kidney or Urinary Problem
32
32
Inflammation
28
28
Hypersensitivity/Allergic reaction
26
26
Stroke/CVA
26
26
Vomiting
26
26
Fatigue
25
25
Apnea
22
22
Pneumonia
20
20
Heart Failure/Congestive Heart Failure
20
20
Nodule
20
20
Chronic Obstructive Pulmonary Disease (COPD)
18
18
Pharyngitis
17
17
Pain
15
15
Cardiac Arrest
15
15
Dry Eye(s)
14
14
Unspecified Eye / Vision Problem
14
14
Unspecified Hepatic or Biliary Problem
13
13
Liver Damage/Dysfunction
13
13
Sneezing
13
13
Low Oxygen Saturation
12
12
Unspecified Infection
12
12
Atrial Fibrillation
12
12
Rash
11
11
Renal Failure
11
11
Swelling/ Edema
11
11
Unspecified Gastrointestinal Problem
10
10
Eye Pain
9
9
High Blood Pressure/ Hypertension
9
9
Bronchitis
9
9
Respiratory Failure
9
9
Burning Sensation
8
8
Angina
8
8
Pulmonary Dysfunction
8
8
Renal Impairment
8
8
Unspecified Ear or Labyrinth Problem
7
7
Myocardial Infarction
7
7
Arrhythmia
7
7
Pulmonary Emphysema
7
7
Choking
7
7
Nasal Obstruction
6
6
Discomfort
6
6
Anxiety
6
6
Confusion/ Disorientation
6
6
Lethargy
6
6
Memory Loss/Impairment
6
6
Hemoptysis
6
6
Fever
5
5
Death
5
5
Abdominal Pain
5
5
Weight Changes
5
5
Respiratory Insufficiency
5
5
Wheezing
5
5
Skin Disorders
5
5
Solid Tumour
4
4
Pulmonary Hypertension
4
4
Eye Infections
4
4
Cognitive Changes
4
4
Unspecified Mental, Emotional or Behavioural Problem
4
4
Malaise
4
4
Bacterial Infection
4
4
Hemorrhage/Bleeding
4
4
Hypoxia
4
4
Red Eye(s)
4
4
Breast Cancer
3
3
Overinflation of Lung
3
3
Loss of Vision
3
3
Tachycardia
3
3
Tinnitus
3
3
Balance Problems
3
3
Convulsion/Seizure
2
2
Unspecified Blood or Lymphatic problem
2
2
Syncope/Fainting
2
2
Eye Burn
2
2
Fluid Discharge
2
2
Patient Problem/Medical Problem
2
2
Chemical Exposure
2
2
Numbness
2
2
Fungal Infection
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Philips Respironics, Inc.
I
Sep-09-2022
2
Philips Respironics, Inc.
I
Jul-15-2021
3
Philips Respironics, Inc.
I
Jul-13-2021
4
Philips Respironics, Inc.
II
May-21-2021
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