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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
2028
2028
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequate User Interface
3334
3334
Defective Component
1866
1866
Device Alarm System
1486
1486
Therapeutic or Diagnostic Output Failure
1447
1447
Incorrect, Inadequate or Imprecise Result or Readings
1439
1439
Battery Problem
1258
1258
Device Sensing Problem
1257
1257
Defective Device
1148
1148
Failure to Power Up
827
827
Power Problem
780
780
Output Problem
773
773
Unexpected Shutdown
746
746
Device Displays Incorrect Message
633
633
No Display/Image
626
626
Defective Alarm
545
545
Electrical /Electronic Property Problem
545
545
Display or Visual Feedback Problem
525
525
Gas/Air Leak
491
491
Excessive Heating
430
430
Mechanical Problem
413
413
Noise, Audible
319
319
Break
306
306
Failure to Sense
299
299
Failure to Calibrate
293
293
Pressure Problem
289
289
Protective Measures Problem
242
242
Failure to Charge
214
214
Failure to Shut Off
211
211
Tidal Volume Fluctuations
210
210
Failure to Run on Battery
204
204
Failure to Deliver
200
200
Loss of Power
194
194
Self-Activation or Keying
191
191
Failure to Read Input Signal
189
189
Display Difficult to Read
186
186
Calibration Problem
179
179
Unintended Power Up
178
178
Circuit Failure
174
174
Computer Operating System Problem
162
162
Complete Loss of Power
162
162
No Flow
160
160
Infusion or Flow Problem
151
151
Appropriate Term/Code Not Available
139
139
Temperature Problem
137
137
Insufficient Flow or Under Infusion
131
131
Poor Quality Image
116
116
Improper Flow or Infusion
114
114
Volume Accuracy Problem
109
109
Increase in Pressure
109
109
Insufficient Information
101
101
Failure of Device to Self-Test
99
99
Obstruction of Flow
96
96
Leak/Splash
90
90
Communication or Transmission Problem
85
85
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
Energy Output Problem
70
70
Gas Output Problem
67
67
Degraded
64
64
Adverse Event Without Identified Device or Use Problem
64
64
Computer Software Problem
63
63
No Audible Alarm
62
62
Grounding Malfunction
62
62
Application Program Freezes, Becomes Nonfunctional
61
61
Intermittent Loss of Power
58
58
Overheating of Device
57
57
Decrease in Pressure
54
54
Mechanical Jam
52
52
Charging Problem
50
50
Vibration
50
50
Failure to Align
49
49
Detachment of Device or Device Component
49
49
Material Integrity Problem
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
Unstable
35
35
No Audible Prompt/Feedback
35
35
Inaccurate Delivery
30
30
Excess Flow or Over-Infusion
30
30
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
Unable to Obtain Readings
24
24
Date/Time-Related Software Problem
23
23
Human-Device Interface Problem
23
23
Physical Resistance/Sticking
22
22
Device Contamination with Chemical or Other Material
20
20
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14519
14519
No Patient Involvement
7672
7672
No Known Impact Or Consequence To Patient
3030
3030
No Consequences Or Impact To Patient
1226
1226
Insufficient Information
559
559
Hypoxia
100
100
Low Oxygen Saturation
87
87
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
May-24-2024
3
Philips Respironics, Inc.
I
Sep-28-2023
4
Philips Respironics, Inc.
II
May-21-2021
5
ResMed Ltd.
I
Feb-07-2020
6
Respironics California, LLC
I
Apr-18-2022
7
Respironics California, LLC
I
Feb-25-2022
8
Respironics California, LLC
I
Jul-22-2021
9
Respironics California, LLC
II
Feb-19-2021
10
Respironics California, LLC
II
Jan-22-2021
11
Respironics California, LLC
II
Jan-22-2021
12
Respironics California, LLC
II
Mar-31-2020
13
Respironics California, LLC
II
Mar-02-2020
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