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TPLC
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Device
ventilator, continuous, non-life-supporting
Regulation Description
Continuous ventilator.
Product Code
MNS
Regulation Number
868.5895
Device Class
2
Premarket Reviews
Manufacturer
Decision
BMC MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BREAS MEDICAL AB
SUBSTANTIALLY EQUIVALENT
1
SMD MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
64
64
2021
254
254
2022
2499
2499
2023
1320
1320
2024
1562
1562
2025
1172
1172
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
5933
5933
Corroded
233
233
Contamination
227
227
Electrical /Electronic Property Problem
176
176
Adverse Event Without Identified Device or Use Problem
172
172
Circuit Failure
76
76
Unexpected Shutdown
61
61
Nonstandard Device
46
46
Failure to Power Up
24
24
Power Problem
21
21
Patient-Device Incompatibility
20
20
Contamination /Decontamination Problem
20
20
Device Emits Odor
19
19
Device Sensing Problem
19
19
Insufficient Information
19
19
Battery Problem
17
17
Material Integrity Problem
13
13
Mechanical Problem
12
12
Pressure Problem
10
10
Noise, Audible
9
9
No Display/Image
9
9
Device Displays Incorrect Message
9
9
Increase in Pressure
9
9
Therapeutic or Diagnostic Output Failure
8
8
Device Alarm System
7
7
No Apparent Adverse Event
6
6
Overheating of Device
6
6
Failure to Charge
5
5
Decrease in Pressure
5
5
Break
5
5
Fire
5
5
Defective Alarm
5
5
Defective Component
5
5
Defective Device
5
5
Device Contamination with Chemical or Other Material
4
4
Patient Device Interaction Problem
4
4
Excessive Heating
4
4
Complete Loss of Power
4
4
No Audible Alarm
3
3
Computer Software Problem
3
3
Smoking
3
3
Material Disintegration
3
3
Self-Activation or Keying
3
3
Failure to Run on Battery
3
3
Temperature Problem
3
3
Leak/Splash
3
3
Protective Measures Problem
2
2
Failure to Calibrate
2
2
Inaccurate Delivery
2
2
Display or Visual Feedback Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4192
4192
Unspecified Respiratory Problem
750
750
Headache
632
632
Dyspnea
600
600
Cancer
413
413
Dizziness
398
398
Cough
255
255
Sore Throat
242
242
Asthma
232
232
Insufficient Information
223
223
Respiratory Tract Infection
215
215
Unspecified Kidney or Urinary Problem
214
214
Nausea
150
150
Skin Inflammation/ Irritation
149
149
Inflammation
145
145
Unspecified Heart Problem
120
120
Vomiting
111
111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
105
105
Hypersensitivity/Allergic reaction
99
99
Unspecified Hepatic or Biliary Problem
73
73
Dry Mouth
72
72
Chronic Obstructive Pulmonary Disease (COPD)
60
60
Chest Pain
55
55
Sleep Dysfunction
47
47
Heart Failure/Congestive Heart Failure
46
46
Pneumonia
38
38
Pulmonary Dysfunction
38
38
Epistaxis
37
37
Stroke/CVA
35
35
Liver Damage/Dysfunction
33
33
Fatigue
31
31
Nodule
26
26
No Patient Involvement
25
25
Apnea
23
23
Bronchitis
20
20
Atrial Fibrillation
19
19
Respiratory Failure
19
19
Pharyngitis
17
17
Low Oxygen Saturation
16
16
Pain
16
16
Cardiovascular Insufficiency
15
15
Dry Eye(s)
15
15
Cardiac Arrest
15
15
Unspecified Eye / Vision Problem
15
15
Renal Failure
14
14
Sneezing
14
14
Unspecified Infection
14
14
Myocardial Infarction
14
14
Unspecified Gastrointestinal Problem
14
14
High Blood Pressure/ Hypertension
13
13
Recalls
Manufacturer
Recall Class
Date Posted
1
Philips Respironics, Inc.
I
Jul-02-2025
2
Philips Respironics, Inc.
I
May-24-2024
3
Philips Respironics, Inc.
I
May-23-2024
4
Philips Respironics, Inc.
I
Sep-09-2022
5
Philips Respironics, Inc.
I
Jul-15-2021
6
Philips Respironics, Inc.
I
Jul-13-2021
7
Philips Respironics, Inc.
II
May-21-2021
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