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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
MAQUET CRITICAL CARE AB
SUBSTANTIALLY EQUIVALENT
1
NIHON KOHDEN ORANGEMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
9350
9350
2020
4170
4170
2021
3790
3790
2022
3277
3277
2023
4567
4567
2024
1455
1455
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequate User Interface
3235
3235
Defective Component
1864
1864
Therapeutic or Diagnostic Output Failure
1447
1447
Device Alarm System
1438
1438
Incorrect, Inadequate or Imprecise Result or Readings
1436
1436
Battery Problem
1256
1256
Device Sensing Problem
1218
1218
Defective Device
1148
1148
Failure to Power Up
815
815
Output Problem
773
773
Power Problem
773
773
Unexpected Shutdown
723
723
Device Displays Incorrect Message
633
633
No Display/Image
609
609
Defective Alarm
540
540
Display or Visual Feedback Problem
522
522
Electrical /Electronic Property Problem
522
522
Gas/Air Leak
474
474
Excessive Heating
420
420
Mechanical Problem
388
388
Noise, Audible
319
319
Break
306
306
Failure to Calibrate
293
293
Pressure Problem
289
289
Failure to Sense
252
252
Protective Measures Problem
241
241
Failure to Charge
206
206
Failure to Shut Off
205
205
Tidal Volume Fluctuations
196
196
Loss of Power
194
194
Self-Activation or Keying
191
191
Failure to Read Input Signal
189
189
Failure to Deliver
186
186
Calibration Problem
179
179
Failure to Run on Battery
177
177
Unintended Power Up
174
174
Display Difficult to Read
172
172
Circuit Failure
168
168
Computer Operating System Problem
162
162
No Flow
160
160
Infusion or Flow Problem
151
151
Appropriate Term/Code Not Available
138
138
Temperature Problem
137
137
Complete Loss of Power
133
133
Insufficient Flow or Under Infusion
128
128
Poor Quality Image
116
116
Improper Flow or Infusion
113
113
Volume Accuracy Problem
109
109
Increase in Pressure
103
103
Insufficient Information
100
100
Failure of Device to Self-Test
99
99
Obstruction of Flow
90
90
Leak/Splash
90
90
Operating System Becomes Nonfunctional
82
82
Crack
81
81
Image Display Error/Artifact
75
75
Key or Button Unresponsive/not Working
75
75
Inaccurate Flow Rate
74
74
Communication or Transmission Problem
73
73
Energy Output Problem
70
70
Gas Output Problem
67
67
Degraded
64
64
Adverse Event Without Identified Device or Use Problem
61
61
Application Program Freezes, Becomes Nonfunctional
61
61
No Audible Alarm
60
60
Intermittent Loss of Power
58
58
Overheating of Device
57
57
Computer Software Problem
56
56
Decrease in Pressure
54
54
Mechanical Jam
52
52
Grounding Malfunction
51
51
Vibration
50
50
Charging Problem
50
50
Detachment of Device or Device Component
49
49
Material Integrity Problem
49
49
Failure to Align
49
49
Erratic or Intermittent Display
48
48
Disconnection
47
47
Component Missing
43
43
Audible Prompt/Feedback Problem
43
43
Failure to Zero
41
41
No Device Output
41
41
Use of Device Problem
38
38
Device Emits Odor
37
37
Loose or Intermittent Connection
35
35
No Audible Prompt/Feedback
35
35
Excess Flow or Over-Infusion
30
30
Inaccurate Delivery
29
29
Intermittent Energy Output
29
29
Connection Problem
29
29
Application Program Problem
27
27
No Pressure
26
26
Blocked Connection
25
25
Use of Incorrect Control/Treatment Settings
25
25
Unstable
24
24
Unable to Obtain Readings
24
24
Date/Time-Related Software Problem
23
23
Human-Device Interface Problem
23
23
Physical Resistance/Sticking
22
22
Intermittent Continuity
18
18
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13955
13955
No Patient Involvement
7672
7672
No Known Impact Or Consequence To Patient
3030
3030
No Consequences Or Impact To Patient
1226
1226
Insufficient Information
555
555
Hypoxia
99
99
Low Oxygen Saturation
82
82
Death
46
46
Dyspnea
28
28
Unspecified Respiratory Problem
16
16
Cardiac Arrest
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Respiratory Arrest
8
8
Respiratory Failure
7
7
Injury
6
6
No Information
6
6
Bradycardia
6
6
Respiratory Distress
5
5
Discomfort
5
5
Increased Respiratory Rate
4
4
Pressure Sores
3
3
Respiratory Acidosis
3
3
No Code Available
3
3
Respiratory Insufficiency
3
3
Pain
3
3
Bacterial Infection
3
3
Fall
3
3
Aspiration Pneumonitis
3
3
Pulmonary Emphysema
2
2
Apnea
2
2
Cardiopulmonary Arrest
2
2
Chest Pain
2
2
Cyanosis
2
2
Fainting
2
2
Hypoventilation
2
2
Pneumonia
2
2
Tachycardia
2
2
Tissue Damage
2
2
Asystole
2
2
Lethargy
2
2
Loss of consciousness
2
2
Fungal Infection
1
1
Respiratory Tract Infection
1
1
Obstruction/Occlusion
1
1
Sweating
1
1
Sleep Dysfunction
1
1
Cognitive Changes
1
1
Anxiety
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
Cancer
1
1
Convulsion/Seizure
1
1
Unspecified Vascular Problem
1
1
Cardiovascular Insufficiency
1
1
Heart Failure/Congestive Heart Failure
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Wheezing
1
1
Nodule
1
1
Urinary Retention
1
1
Vomiting
1
1
Pneumothorax
1
1
Renal Failure
1
1
Septic Shock
1
1
Pleural Effusion
1
1
Infiltration into Tissue
1
1
Inflammation
1
1
Congenital Defect/Deformity
1
1
Abnormal Blood Gases
1
1
Bruise/Contusion
1
1
Encephalopathy
1
1
Asphyxia
1
1
Hematoma
1
1
High Blood Pressure/ Hypertension
1
1
Low Blood Pressure/ Hypotension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DRE Medical Group Inc
II
Jun-29-2023
2
Philips Respironics, Inc.
I
Sep-28-2023
3
Philips Respironics, Inc.
II
May-21-2021
4
ResMed Ltd.
I
Feb-07-2020
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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