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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
1. K191624
F&P Nivairo RT047 Vented Hospital Full Face Mask,
...
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
1776
1776
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequate User Interface
3289
3289
Defective Component
1864
1864
Device Alarm System
1462
1462
Therapeutic or Diagnostic Output Failure
1447
1447
Incorrect, Inadequate or Imprecise Result or Readings
1437
1437
Battery Problem
1256
1256
Device Sensing Problem
1249
1249
Defective Device
1148
1148
Failure to Power Up
821
821
Power Problem
777
777
Output Problem
773
773
Unexpected Shutdown
732
732
Device Displays Incorrect Message
633
633
No Display/Image
621
621
Defective Alarm
541
541
Electrical /Electronic Property Problem
540
540
Display or Visual Feedback Problem
522
522
Gas/Air Leak
482
482
Excessive Heating
428
428
Mechanical Problem
400
400
Noise, Audible
319
319
Break
306
306
Failure to Calibrate
293
293
Pressure Problem
289
289
Failure to Sense
282
282
Protective Measures Problem
242
242
Failure to Charge
210
210
Failure to Shut Off
207
207
Tidal Volume Fluctuations
203
203
Failure to Run on Battery
197
197
Loss of Power
194
194
Failure to Deliver
194
194
Self-Activation or Keying
191
191
Failure to Read Input Signal
189
189
Calibration Problem
179
179
Unintended Power Up
176
176
Display Difficult to Read
175
175
Circuit Failure
170
170
Computer Operating System Problem
162
162
No Flow
160
160
Complete Loss of Power
152
152
Infusion or Flow Problem
151
151
Appropriate Term/Code Not Available
138
138
Temperature Problem
137
137
Insufficient Flow or Under Infusion
129
129
Poor Quality Image
116
116
Improper Flow or Infusion
113
113
Volume Accuracy Problem
109
109
Increase in Pressure
107
107
Insufficient Information
101
101
Failure of Device to Self-Test
99
99
Obstruction of Flow
93
93
Leak/Splash
90
90
Operating System Becomes Nonfunctional
82
82
Crack
81
81
Communication or Transmission Problem
78
78
Key or Button Unresponsive/not Working
75
75
Image Display Error/Artifact
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
62
62
Application Program Freezes, Becomes Nonfunctional
61
61
Computer Software Problem
61
61
Grounding Malfunction
61
61
No Audible Alarm
60
60
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
No Audible Prompt/Feedback
35
35
Unstable
30
30
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
18
18
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14271
14271
No Patient Involvement
7672
7672
No Known Impact Or Consequence To Patient
3030
3030
No Consequences Or Impact To Patient
1226
1226
Insufficient Information
557
557
Hypoxia
100
100
Low Oxygen Saturation
84
84
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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