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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
1314
1314
2024
326
326
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
3900
3900
Corroded
233
233
Contamination
72
72
Nonstandard Device
46
46
Device Displays Incorrect Message
42
42
Battery Problem
39
39
Adverse Event Without Identified Device or Use Problem
36
36
Failure to Power Up
35
35
Electrical /Electronic Property Problem
34
34
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
19
19
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
2673
2673
Dyspnea
559
559
Headache
388
388
Unspecified Respiratory Problem
330
330
Cough
238
238
Sore Throat
231
231
Respiratory Tract Infection
183
183
No Patient Involvement
176
176
Dizziness
168
168
Cancer
153
153
No Known Impact Or Consequence To Patient
77
77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
71
71
Asthma
69
69
Dry Mouth
67
67
Insufficient Information
64
64
Unspecified Heart Problem
61
61
Nausea
61
61
No Consequences Or Impact To Patient
53
53
Unspecified Kidney or Urinary Problem
52
52
Chest Pain
48
48
Skin Inflammation/ Irritation
45
45
Sleep Dysfunction
41
41
Hypersensitivity/Allergic reaction
35
35
Epistaxis
35
35
Inflammation
33
33
Stroke/CVA
29
29
Vomiting
28
28
Fatigue
27
27
Chronic Obstructive Pulmonary Disease (COPD)
26
26
Heart Failure/Congestive Heart Failure
24
24
Pneumonia
22
22
Apnea
22
22
Nodule
21
21
Pharyngitis
17
17
Pain
16
16
Liver Damage/Dysfunction
16
16
Cardiac Arrest
15
15
Unspecified Hepatic or Biliary Problem
15
15
Unspecified Eye / Vision Problem
15
15
Dry Eye(s)
14
14
Atrial Fibrillation
13
13
Sneezing
13
13
Renal Failure
12
12
Low Oxygen Saturation
12
12
Unspecified Infection
12
12
Rash
12
12
Bronchitis
11
11
Swelling/ Edema
11
11
Unspecified Gastrointestinal Problem
10
10
Pulmonary Dysfunction
10
10
Respiratory Failure
10
10
High Blood Pressure/ Hypertension
9
9
Renal Impairment
9
9
Eye Pain
9
9
Angina
8
8
Burning Sensation
8
8
Choking
7
7
Arrhythmia
7
7
Pulmonary Emphysema
7
7
Myocardial Infarction
7
7
Unspecified Ear or Labyrinth Problem
7
7
Solid Tumour
6
6
Memory Loss/Impairment
6
6
Hemoptysis
6
6
Abdominal Pain
6
6
Nasal Obstruction
6
6
Confusion/ Disorientation
6
6
Lethargy
6
6
Anxiety
6
6
Discomfort
6
6
Weight Changes
5
5
Death
5
5
Fever
5
5
Skin Disorders
5
5
Pulmonary Hypertension
5
5
Respiratory Insufficiency
5
5
Wheezing
5
5
Eye Infections
4
4
Unspecified Mental, Emotional or Behavioural Problem
4
4
Hemorrhage/Bleeding
4
4
Hypoxia
4
4
Red Eye(s)
4
4
Bacterial Infection
4
4
Cognitive Changes
4
4
Malaise
4
4
Overinflation of Lung
3
3
Loss of Vision
3
3
Tachycardia
3
3
Tinnitus
3
3
Balance Problems
3
3
Breast Cancer
3
3
Bradycardia
2
2
Pulmonary Embolism
2
2
Aneurysm
2
2
Bruise/Contusion
2
2
Pneumothorax
2
2
Muscle Weakness
2
2
Hematoma
2
2
Low Blood Pressure/ Hypotension
2
2
Emotional Changes
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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