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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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequate User Interface
2187
2187
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
1149
1149
Device Alarm System
1083
1083
Device Displays Incorrect Message
993
993
Failure to Power Up
792
792
Output Problem
791
791
Device Sensing Problem
661
661
No Display/Image
585
585
Power Problem
581
581
Display or Visual Feedback Problem
490
490
Defective Alarm
440
440
Unexpected Shutdown
418
418
Break
341
341
Noise, Audible
327
327
Failure to Calibrate
313
313
Excessive Heating
282
282
Pressure Problem
276
276
Gas/Air Leak
276
276
Mechanical Problem
254
254
Loss of Power
247
247
Failure to Read Input Signal
246
246
Protective Measures Problem
244
244
Calibration Problem
206
206
Self-Activation or Keying
202
202
Temperature Problem
201
201
Appropriate Term/Code Not Available
197
197
Failure to Charge
189
189
Failure to Shut Off
188
188
Computer Operating System Problem
173
173
Electrical /Electronic Property Problem
152
152
No Flow
133
133
Failure of Device to Self-Test
126
126
Infusion or Flow Problem
124
124
Tidal Volume Fluctuations
123
123
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
92
92
Crack
88
88
Improper Flow or Infusion
87
87
Unintended Power Up
83
83
Insufficient Information
80
80
Application Program Freezes, Becomes Nonfunctional
78
78
Device Inoperable
77
77
Increase in Pressure
77
77
Image Display Error/Artifact
76
76
Display Difficult to Read
76
76
Key or Button Unresponsive/not Working
75
75
Failure to Deliver
74
74
Volume Accuracy Problem
71
71
Energy Output Problem
70
70
Inaccurate Flow Rate
69
69
Overheating of Device
68
68
Gas Output Problem
66
66
Failure to Sense
64
64
Adverse Event Without Identified Device or Use Problem
64
64
Charging Problem
64
64
Obstruction of Flow
61
61
Intermittent Loss of Power
60
60
Disconnection
55
55
No Audible Alarm
54
54
Failure to Run on Battery
54
54
Degraded
53
53
Failure to Align
52
52
Circuit Failure
51
51
Vibration
51
51
Component Missing
48
48
No Device Output
45
45
Use of Device Problem
43
43
Audible Prompt/Feedback Problem
43
43
Detachment of Device or Device Component
41
41
Failure to Zero
41
41
Computer Software Problem
41
41
Loose or Intermittent Connection
40
40
Material Integrity Problem
40
40
Mechanical Jam
40
40
Device Emits Odor
37
37
Decrease in Pressure
37
37
No Audible Prompt/Feedback
35
35
Erratic or Intermittent Display
32
32
Connection Problem
32
32
Application Program Problem
31
31
Inaccurate Delivery
30
30
Intermittent Energy Output
29
29
Complete Loss of Power
28
28
Use of Incorrect Control/Treatment Settings
27
27
Unable to Obtain Readings
24
24
Human-Device Interface Problem
24
24
Inappropriate or Unexpected Reset
23
23
Blocked Connection
23
23
Communication or Transmission Problem
23
23
No Pressure
23
23
Nonstandard Device
23
23
Physical Resistance/Sticking
22
22
Electrical Power Problem
20
20
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
8521
8521
No Clinical Signs, Symptoms or Conditions
8004
8004
No Known Impact Or Consequence To Patient
4122
4122
No Consequences Or Impact To Patient
1427
1427
Insufficient Information
524
524
Low Oxygen Saturation
90
90
Hypoxia
82
82
Death
75
75
Dyspnea
19
19
No Information
11
11
Cardiac Arrest
11
11
Unspecified Respiratory Problem
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
No Code Available
7
7
Respiratory Distress
7
7
Injury
6
6
Cardiopulmonary Arrest
6
6
Bradycardia
6
6
Respiratory Arrest
6
6
Respiratory Failure
6
6
Pressure Sores
4
4
Pain
4
4
Pneumonia
3
3
Discomfort
3
3
Aspiration Pneumonitis
3
3
Loss of consciousness
3
3
Fall
3
3
Bacterial Infection
3
3
Patient Problem/Medical Problem
2
2
Apnea
2
2
Tissue Damage
2
2
Asystole
2
2
Increased Respiratory Rate
2
2
Pulmonary Emphysema
2
2
Cyanosis
2
2
Lethargy
2
2
Fainting
2
2
Chest Pain
2
2
Tachycardia
2
2
Vomiting
1
1
Distress
1
1
Pleural Effusion
1
1
Adult Respiratory Distress Syndrome
1
1
Pneumothorax
1
1
Ventilator Dependent
1
1
High Blood Pressure/ Hypertension
1
1
Infiltration into Tissue
1
1
Encephalopathy
1
1
Fungal Infection
1
1
Sweating
1
1
Cognitive Changes
1
1
Hypoxia in Utero
1
1
Heart Failure/Congestive Heart Failure
1
1
Congenital Defect/Deformity
1
1
Hematoma
1
1
Low Blood Pressure/ Hypotension
1
1
Inflammation
1
1
Renal Failure
1
1
Septic Shock
1
1
Wheezing
1
1
Respiratory Acidosis
1
1
Foreign Body In Patient
1
1
Asphyxia
1
1
Cardiovascular Insufficiency
1
1
Urinary Retention
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Therapeutic Response, Decreased
1
1
Respiratory Tract Infection
1
1
Abnormal Blood Gases
1
1
Bruise/Contusion
1
1
Respiratory Insufficiency
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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