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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
MDR Year
MDR Reports
MDR Events
2019
275
275
2020
64
64
2021
254
254
2022
2499
2499
2023
1313
1313
2024
154
154
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
3750
3750
Corroded
233
233
Contamination
70
70
Nonstandard Device
46
46
Device Displays Incorrect Message
42
42
Battery Problem
39
39
Failure to Power Up
34
34
Electrical /Electronic Property Problem
33
33
Power Problem
26
26
Output Problem
26
26
Pressure Problem
24
24
Unexpected Shutdown
24
24
Device Alarm System
23
23
Adverse Event Without Identified Device or Use Problem
21
21
Therapeutic or Diagnostic Output Failure
20
20
Patient-Device Incompatibility
20
20
Circuit Failure
18
18
Protective Measures Problem
17
17
Insufficient Information
16
16
Device Emits Odor
14
14
Increase in Pressure
14
14
Defective Component
13
13
Defective Device
11
11
Noise, Audible
11
11
Material Integrity Problem
10
10
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Failure to Charge
10
10
Mechanical Problem
9
9
Self-Activation or Keying
9
9
Display or Visual Feedback Problem
9
9
Failure to Calibrate
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
2622
2622
Dyspnea
548
548
Headache
357
357
Unspecified Respiratory Problem
276
276
Cough
236
236
Sore Throat
229
229
Respiratory Tract Infection
177
177
No Patient Involvement
176
176
Dizziness
140
140
Cancer
111
111
No Known Impact Or Consequence To Patient
77
77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
68
68
Dry Mouth
67
67
Insufficient Information
59
59
Nausea
54
54
Unspecified Heart Problem
53
53
No Consequences Or Impact To Patient
53
53
Chest Pain
47
47
Asthma
41
41
Sleep Dysfunction
39
39
Epistaxis
35
35
Skin Inflammation/ Irritation
34
34
Unspecified Kidney or Urinary Problem
26
26
Fatigue
25
25
Inflammation
25
25
Stroke/CVA
24
24
Hypersensitivity/Allergic reaction
22
22
Vomiting
22
22
Apnea
21
21
Pneumonia
19
19
Heart Failure/Congestive Heart Failure
19
19
Nodule
19
19
Chronic Obstructive Pulmonary Disease (COPD)
18
18
Pharyngitis
17
17
Pain
14
14
Dry Eye(s)
14
14
Unspecified Eye / Vision Problem
14
14
Cardiac Arrest
13
13
Sneezing
13
13
Low Oxygen Saturation
12
12
Atrial Fibrillation
12
12
Unspecified Infection
12
12
Unspecified Hepatic or Biliary Problem
12
12
Swelling/ Edema
11
11
Rash
11
11
Renal Failure
11
11
Liver Damage/Dysfunction
11
11
Unspecified Gastrointestinal Problem
10
10
Eye Pain
9
9
Bronchitis
9
9
Angina
8
8
High Blood Pressure/ Hypertension
8
8
Respiratory Failure
8
8
Burning Sensation
8
8
Renal Impairment
8
8
Unspecified Ear or Labyrinth Problem
7
7
Choking
7
7
Myocardial Infarction
7
7
Arrhythmia
7
7
Pulmonary Emphysema
7
7
Pulmonary Dysfunction
6
6
Memory Loss/Impairment
6
6
Hemoptysis
6
6
Nasal Obstruction
6
6
Discomfort
6
6
Anxiety
6
6
Confusion/ Disorientation
6
6
Lethargy
6
6
Weight Changes
5
5
Fever
5
5
Death
5
5
Abdominal Pain
5
5
Respiratory Insufficiency
5
5
Wheezing
5
5
Skin Disorders
5
5
Solid Tumour
4
4
Eye Infections
4
4
Pulmonary Hypertension
4
4
Bacterial Infection
4
4
Hemorrhage/Bleeding
4
4
Red Eye(s)
4
4
Hypoxia
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
Unspecified Mental, Emotional or Behavioural Problem
3
3
Breast Cancer
3
3
Bradycardia
2
2
Cyanosis
2
2
Emotional Changes
2
2
Pulmonary Embolism
2
2
Aneurysm
2
2
Bruise/Contusion
2
2
Hair Loss
2
2
Muscle Weakness
2
2
Respiratory Distress
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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