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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
PHILIPS RESPIRONICS, INC
SUBSTANTIALLY EQUIVALENT
1
RESMED LTD
SUBSTANTIALLY EQUIVALENT
3
RESMED LTD.
SUBSTANTIALLY EQUIVALENT
10
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
SUBSTANTIALLY EQUIVALENT
2
RESPIRONICS, INC.
SUBSTANTIALLY EQUIVALENT
5
SMD MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
1
SMD MANUFACTURING, LLC
SUBSTANTIALLY EQUIVALENT
1
SUNRISE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
50
50
2016
16
16
2017
20
20
2018
22
22
2019
275
275
2020
64
64
2021
254
254
2022
2499
2499
2023
1314
1314
2024
971
971
Device Problems
MDRs with this Device Problem
Events in those MDRs
Degraded
4482
4482
Corroded
233
233
Adverse Event Without Identified Device or Use Problem
79
79
Contamination
77
77
Device Displays Incorrect Message
65
65
Nonstandard Device
46
46
Battery Problem
42
42
Device Alarm System
40
40
Electrical /Electronic Property Problem
40
40
Failure to Power Up
38
38
Unexpected Shutdown
36
36
Power Problem
28
28
Pressure Problem
26
26
Output Problem
26
26
Insufficient Information
24
24
Patient-Device Incompatibility
21
21
Therapeutic or Diagnostic Output Failure
20
20
Circuit Failure
19
19
Increase in Pressure
19
19
Protective Measures Problem
17
17
Defective Component
15
15
Device Operates Differently Than Expected
14
14
Device Emits Odor
14
14
No Audible Alarm
13
13
Loss of Power
13
13
Noise, Audible
13
13
Failure to Charge
12
12
Defective Device
12
12
Material Integrity Problem
11
11
Mechanical Problem
11
11
Display or Visual Feedback Problem
10
10
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Self-Activation or Keying
10
10
Failure to Calibrate
10
10
Overheating of Device
9
9
Break
9
9
Decrease in Pressure
9
9
No Display/Image
7
7
Defective Alarm
7
7
No Flow
7
7
Crack
6
6
Fire
6
6
Component Missing
5
5
Device Inoperable
5
5
Temperature Problem
5
5
Computer Operating System Problem
5
5
Contamination /Decontamination Problem
4
4
Patient Device Interaction Problem
4
4
Smoking
4
4
Failure to Run on Battery
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2875
2875
Dyspnea
567
567
Unspecified Respiratory Problem
566
566
Headache
533
533
Dizziness
312
312
Cancer
299
299
Cough
245
245
Sore Throat
232
232
Respiratory Tract Infection
207
207
No Patient Involvement
198
198
Asthma
176
176
Unspecified Kidney or Urinary Problem
151
151
Nausea
116
116
Skin Inflammation/ Irritation
106
106
No Known Impact Or Consequence To Patient
105
105
Unspecified Heart Problem
104
104
Inflammation
100
100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
86
86
Insufficient Information
85
85
Vomiting
80
80
Hypersensitivity/Allergic reaction
78
78
No Consequences Or Impact To Patient
70
70
Dry Mouth
67
67
Chest Pain
49
49
Unspecified Hepatic or Biliary Problem
44
44
Sleep Dysfunction
43
43
Chronic Obstructive Pulmonary Disease (COPD)
36
36
Epistaxis
36
36
Heart Failure/Congestive Heart Failure
34
34
Stroke/CVA
31
31
Liver Damage/Dysfunction
31
31
Fatigue
28
28
Pneumonia
28
28
Apnea
22
22
No Information
22
22
Nodule
21
21
Respiratory Failure
19
19
Pharyngitis
17
17
Death
17
17
Low Oxygen Saturation
16
16
Cardiac Arrest
16
16
Pain
16
16
Unspecified Eye / Vision Problem
15
15
Renal Failure
14
14
Atrial Fibrillation
14
14
Dry Eye(s)
14
14
Pulmonary Dysfunction
14
14
Bronchitis
13
13
Sneezing
13
13
Unspecified Infection
12
12
Recalls
Manufacturer
Recall Class
Date Posted
1
Philips Respironics, Inc.
I
May-24-2024
2
Philips Respironics, Inc.
I
May-23-2024
3
Philips Respironics, Inc.
I
Sep-09-2022
4
Philips Respironics, Inc.
I
Jul-15-2021
5
Philips Respironics, Inc.
I
Jul-13-2021
6
Philips Respironics, Inc.
II
May-21-2021
7
Respironics California Inc
I
Jul-07-2009
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