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TPLC
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Device
ventilator, continuous, minimal ventilatory support, facility use
Product Code
MNT
Regulation Number
868.5895
Device Class
2
Premarket Reviews
Manufacturer
Decision
FISHER & PAYKEL HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
FISHER AND PAYKEL HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
1
NIHON KOHDEN ORANGEMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
2878
2878
2018
2202
2202
2019
9350
9350
2020
4170
4170
2021
3791
3791
2022
2015
2015
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
2434
2434
Defective Component
1954
1954
Inadequate User Interface
1888
1888
Therapeutic or Diagnostic Output Failure
1447
1447
Incorrect, Inadequate or Imprecise Resultor Readings
1439
1439
Defective Device
1265
1265
Battery Problem
1156
1156
Device Alarm System
1068
1068
Failure to Power Up
906
906
Output Problem
789
789
No Display/Image
699
699
Device Operates Differently Than Expected
588
588
Device Sensing Problem
534
534
Power Problem
527
527
Device Inoperable
476
476
Display or Visual Feedback Problem
465
465
Defective Alarm
436
436
Break
366
366
Loss of Power
346
346
Unexpected Shutdown
343
343
Noise, Audible
335
335
Failure to Calibrate
325
325
Failure to Read Input Signal
269
269
Pressure Problem
255
255
Temperature Problem
245
245
Protective Measures Problem
239
239
Nonstandard Device
237
237
Excessive Heating
234
234
Failure to Charge
233
233
Gas Leak
229
229
Calibration Problem
228
228
Mechanical Problem
217
217
Self-Activation or Keying
215
215
Appropriate Term/Code Not Available
197
197
Failure to Shut Off
187
187
Computer Operating System Problem
176
176
Failure of Device to Self-Test
140
140
Tidal Volume Fluctuations
134
134
No Flow
133
133
Electrical /Electronic Property Problem
132
132
Leak/Splash
127
127
Poor Quality Image
123
123
Operating System Becomes Nonfunctional
101
101
Infusion or Flow Problem
101
101
Crack
88
88
Overheating of Device
83
83
Insufficient Information
82
82
Improper Flow or Infusion
80
80
Insufficient Flow or Under Infusion
79
79
Image Display Error/Artifact
79
79
Application Program Freezes, Becomes Nonfunctional
77
77
Key or Button Unresponsive/not Working
75
75
Increase in Pressure
75
75
Adverse Event Without Identified Device or Use Problem
72
72
Charging Problem
71
71
Energy Output Problem
70
70
Failure to Sense
67
67
Inaccurate Flow Rate
66
66
Gas Output Problem
61
61
Unintended Power Up
61
61
Display Difficult to Read
60
60
Volume Accuracy Problem
60
60
Failure to Deliver
60
60
Disconnection
59
59
No Audible Alarm
58
58
Application Interface Becomes Non-Functional Or Program Exits Abnormally
57
57
Failure to Align
57
57
Intermittent Loss of Power
57
57
Vibration
53
53
Failure to Run on Battery
53
53
Obstruction of Flow
52
52
Component Missing
51
51
Device Stops Intermittently
51
51
Degraded
50
50
Use of Device Problem
47
47
Device Emits Odor
46
46
No Device Output
45
45
Failure to Zero
44
44
Circuit Failure
43
43
Audible Prompt/Feedback Problem
43
43
Mechanical Jam
41
41
Computer Software Problem
41
41
Loose or Intermittent Connection
41
41
Connection Problem
38
38
Detachment of Device or Device Component
38
38
No Audible Prompt/Feedback
34
34
Communication or Transmission Problem
33
33
Application Program Problem
33
33
Material Integrity Problem
31
31
Decrease in Pressure
31
31
Erratic or Intermittent Display
31
31
Failure To Run On AC/DC
30
30
Inaccurate Delivery
30
30
Intermittent Energy Output
29
29
Incorrect Or Inadequate Test Results
27
27
Use of Incorrect Control Settings
27
27
Intermittent Continuity
25
25
Inappropriate or Unexpected Reset
25
25
Complete Loss of Power
25
25
Unable to Obtain Readings
24
24
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
9805
9805
No Clinical Signs, Symptoms or Conditions
6754
6754
No Known Impact Or Consequence To Patient
5284
5284
No Consequences Or Impact To Patient
1787
1787
Insufficient Information
520
520
Low Oxygen Saturation
97
97
Death
89
89
Hypoxia
72
72
No Information
38
38
Dyspnea
17
17
Respiratory Distress
14
14
Cardiac Arrest
11
11
Cardiopulmonary Arrest
9
9
No Code Available
9
9
Injury
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Unspecified Respiratory Problem
7
7
Bradycardia
7
7
Respiratory Failure
6
6
Respiratory Arrest
5
5
Loss of consciousness
4
4
Pressure Sores
4
4
Bacterial Infection
4
4
Pain
4
4
Cyanosis
3
3
Fall
3
3
Discomfort
3
3
Patient Problem/Medical Problem
3
3
Aspiration Pneumonitis
3
3
Hypoventilation
2
2
Asystole
2
2
Increased Respiratory Rate
2
2
Lethargy
2
2
Abdominal Distention
2
2
Complaint, Ill-Defined
2
2
Ventilator Dependent
2
2
Pulmonary Emphysema
2
2
Apnea
2
2
Chest Pain
2
2
Fainting
2
2
Tachycardia
2
2
Tissue Damage
2
2
Pneumonia
2
2
Pneumothorax
1
1
Renal Failure
1
1
Unspecified Infection
1
1
Infiltration into Tissue
1
1
Inflammation
1
1
Urinary Retention
1
1
Vomiting
1
1
Septic Shock
1
1
Bruise/Contusion
1
1
Abnormal Blood Gases
1
1
Adult Respiratory Distress Syndrome
1
1
Encephalopathy
1
1
Asphyxia
1
1
Flatus
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
High Blood Pressure/ Hypertension
1
1
Low Blood Pressure/ Hypotension
1
1
Coma
1
1
Diabetic Ketoacidosis
1
1
Fungal Infection
1
1
Sweating
1
1
Chest Tightness/Pressure
1
1
Distress
1
1
Hypoxia in Utero
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Therapeutic Response, Decreased
1
1
Respiratory Acidosis
1
1
Cognitive Changes
1
1
Hematuria
1
1
Cardiovascular Insufficiency
1
1
Heart Failure/Congestive Heart Failure
1
1
Foreign Body In Patient
1
1
Respiratory Insufficiency
1
1
Wheezing
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Philips Respironics, Inc.
II
May-21-2021
2
ResMed Ltd.
I
Feb-07-2020
3
Respironics California Inc
I
May-18-2017
4
Respironics California Inc
II
Mar-27-2017
5
Respironics California, LLC
I
Apr-18-2022
6
Respironics California, LLC
I
Feb-25-2022
7
Respironics California, LLC
I
Jul-22-2021
8
Respironics California, LLC
II
Feb-19-2021
9
Respironics California, LLC
II
Jan-22-2021
10
Respironics California, LLC
II
Jan-22-2021
11
Respironics California, LLC
II
Mar-31-2020
12
Respironics California, LLC
II
Mar-02-2020
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