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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
NIHON KOHDEN ORANGEMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
2202
2202
2019
9350
9350
2020
4170
4170
2021
3791
3791
2022
3277
3277
2023
644
644
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequate User Interface
2318
2318
Defective Component
1915
1915
Therapeutic or Diagnostic Output Failure
1446
1446
Incorrect, Inadequate or Imprecise Result or Readings
1440
1440
Defective Device
1259
1259
Battery Problem
1208
1208
Device Alarm System
1133
1133
Device Displays Incorrect Message
993
993
Failure to Power Up
814
814
Output Problem
791
791
Device Sensing Problem
756
756
Power Problem
621
621
No Display/Image
598
598
Display or Visual Feedback Problem
495
495
Defective Alarm
458
458
Unexpected Shutdown
443
443
Break
344
344
Noise, Audible
328
328
Failure to Calibrate
315
315
Excessive Heating
300
300
Gas/Air Leak
293
293
Pressure Problem
279
279
Mechanical Problem
271
271
Loss of Power
247
247
Failure to Read Input Signal
246
246
Protective Measures Problem
245
245
Calibration Problem
207
207
Self-Activation or Keying
202
202
Temperature Problem
201
201
Appropriate Term/Code Not Available
197
197
Failure to Charge
191
191
Failure to Shut Off
189
189
Computer Operating System Problem
173
173
Electrical /Electronic Property Problem
154
154
No Flow
148
148
Infusion or Flow Problem
128
128
Failure of Device to Self-Test
127
127
Tidal Volume Fluctuations
127
127
Device Operates Differently Than Expected
122
122
Poor Quality Image
116
116
Operating System Becomes Nonfunctional
98
98
Leak/Splash
96
96
Insufficient Flow or Under Infusion
96
96
Improper Flow or Infusion
95
95
Unintended Power Up
92
92
Crack
88
88
Display Difficult to Read
88
88
Failure to Deliver
82
82
Insufficient Information
81
81
Increase in Pressure
80
80
Application Program Freezes, Becomes Nonfunctional
78
78
Volume Accuracy Problem
77
77
Device Inoperable
77
77
Image Display Error/Artifact
76
76
Key or Button Unresponsive/not Working
75
75
Failure to Sense
70
70
Energy Output Problem
70
70
Inaccurate Flow Rate
69
69
Overheating of Device
68
68
Obstruction of Flow
68
68
Gas Output Problem
66
66
Charging Problem
65
65
Adverse Event Without Identified Device or Use Problem
65
65
Intermittent Loss of Power
60
60
Disconnection
56
56
No Audible Alarm
55
55
Failure to Run on Battery
55
55
Degraded
54
54
Circuit Failure
54
54
Failure to Align
52
52
Vibration
51
51
Component Missing
48
48
No Device Output
45
45
Use of Device Problem
43
43
Material Integrity Problem
43
43
Audible Prompt/Feedback Problem
43
43
Computer Software Problem
42
42
Failure to Zero
41
41
Decrease in Pressure
41
41
Mechanical Jam
41
41
Detachment of Device or Device Component
41
41
Loose or Intermittent Connection
40
40
Device Emits Odor
38
38
No Audible Prompt/Feedback
35
35
Erratic or Intermittent Display
34
34
Connection Problem
32
32
Application Program Problem
31
31
Inaccurate Delivery
30
30
Communication or Transmission Problem
29
29
Complete Loss of Power
29
29
Intermittent Energy Output
29
29
Use of Incorrect Control/Treatment Settings
27
27
Unable to Obtain Readings
24
24
No Pressure
24
24
Human-Device Interface Problem
24
24
Inappropriate or Unexpected Reset
23
23
Blocked Connection
23
23
Excess Flow or Over-Infusion
23
23
Nonstandard Device
23
23
Physical Resistance/Sticking
22
22
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
8646
8646
No Patient Involvement
8521
8521
No Known Impact Or Consequence To Patient
4122
4122
No Consequences Or Impact To Patient
1427
1427
Insufficient Information
526
526
Low Oxygen Saturation
91
91
Hypoxia
82
82
Death
75
75
Dyspnea
20
20
Cardiac Arrest
11
11
No Information
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Unspecified Respiratory Problem
8
8
No Code Available
7
7
Respiratory Distress
7
7
Cardiopulmonary Arrest
6
6
Bradycardia
6
6
Respiratory Arrest
6
6
Respiratory Failure
6
6
Injury
6
6
Pressure Sores
4
4
Pain
4
4
Fall
3
3
Pneumonia
3
3
Bacterial Infection
3
3
Loss of consciousness
3
3
Aspiration Pneumonitis
3
3
Discomfort
3
3
Lethargy
2
2
Asystole
2
2
Patient Problem/Medical Problem
2
2
Increased Respiratory Rate
2
2
Apnea
2
2
Chest Pain
2
2
Cyanosis
2
2
Fainting
2
2
Pulmonary Emphysema
2
2
Tachycardia
2
2
Tissue Damage
2
2
Urinary Retention
1
1
Vomiting
1
1
Pneumothorax
1
1
Renal Failure
1
1
Septic Shock
1
1
Asphyxia
1
1
Hematoma
1
1
High Blood Pressure/ Hypertension
1
1
Low Blood Pressure/ Hypotension
1
1
Pleural Effusion
1
1
Infiltration into Tissue
1
1
Inflammation
1
1
Encephalopathy
1
1
Bruise/Contusion
1
1
Congenital Defect/Deformity
1
1
Abnormal Blood Gases
1
1
Adult Respiratory Distress Syndrome
1
1
Cognitive Changes
1
1
Respiratory Acidosis
1
1
Fungal Infection
1
1
Respiratory Tract Infection
1
1
Sweating
1
1
Distress
1
1
Ventilator Dependent
1
1
Hypoxia in Utero
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Therapeutic Response, Decreased
1
1
Respiratory Insufficiency
1
1
Wheezing
1
1
Cardiovascular Insufficiency
1
1
Heart Failure/Congestive Heart Failure
1
1
Foreign Body In Patient
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, LLC
I
Apr-18-2022
4
Respironics California, LLC
I
Feb-25-2022
5
Respironics California, LLC
I
Jul-22-2021
6
Respironics California, LLC
II
Feb-19-2021
7
Respironics California, LLC
II
Jan-22-2021
8
Respironics California, LLC
II
Jan-22-2021
9
Respironics California, LLC
II
Mar-31-2020
10
Respironics California, LLC
II
Mar-02-2020
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