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TPLC
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Device
humidifier, respiratory gas, (direct patient interface)
Product Code
BTT
Regulation Number
868.5450
Device Class
2
Premarket Reviews
Manufacturer
Decision
FISHER & PAYKEL HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
FISHER & PAYKEL HEALTHCARE LTD
SUBSTANTIALLY EQUIVALENT
2
FISHER & PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
FISHER &PAYKEL HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
PERMA PURE LLC
SUBSTANTIALLY EQUIVALENT
1
TNI MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
VAPOTHERM INC.
SUBSTANTIALLY EQUIVALENT
1
VAPOTHERM, INC.
SUBSTANTIALLY EQUIVALENT
1
VINCENT HEALTHCARE PRODUCTS LIMITED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
918
918
2019
894
894
2020
1188
1188
2021
1508
1508
2022
751
751
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Alarm
2786
2786
Break
322
322
Leak/Splash
307
307
Insufficient Heating
304
304
Material Split, Cut or Torn
290
290
Crack
272
272
Fluid/Blood Leak
197
197
Failure to Power Up
186
186
Device Alarm System
126
126
Detachment of Device or Device Component
104
104
Complete Loss of Power
82
82
Power Problem
57
57
Gas/Air Leak
54
54
Adverse Event Without Identified Device or Use Problem
52
52
Disconnection
50
50
Melted
49
49
Overfill
42
42
Temperature Problem
40
40
Defective Alarm
40
40
Mechanical Problem
38
38
Therapeutic or Diagnostic Output Failure
32
32
Overheating of Device
30
30
Material Puncture/Hole
27
27
No Audible Prompt/Feedback
27
27
Use of Device Problem
26
26
Defective Component
25
25
Infusion or Flow Problem
21
21
Improper Flow or Infusion
19
19
Obstruction of Flow
18
18
Defective Device
18
18
Device Displays Incorrect Message
18
18
Unexpected Shutdown
17
17
No Apparent Adverse Event
16
16
Insufficient Information
16
16
Output Problem
16
16
No Flow
15
15
Improper or Incorrect Procedure or Method
15
15
Misconnection
15
15
Protective Measures Problem
14
14
Difficult to Open or Close
13
13
Incorrect, Inadequate or Imprecise Result or Readings
13
13
Loose or Intermittent Connection
13
13
Connection Problem
12
12
Moisture or Humidity Problem
12
12
Failure to Deliver
12
12
Loss of Power
11
11
Fire
10
10
Device Sensing Problem
10
10
Material Integrity Problem
9
9
Failure of Device to Self-Test
9
9
Device Handling Problem
9
9
Intermittent Loss of Power
9
9
Device Emits Odor
8
8
Unintended Movement
8
8
False Alarm
8
8
Stretched
8
8
Noise, Audible
8
8
Display or Visual Feedback Problem
7
7
Filling Problem
7
7
Contamination /Decontamination Problem
6
6
Inaudible or Unclear Audible Prompt/Feedback
6
6
Failure to Sense
6
6
Device Issue
5
5
Sparking
5
5
Failure to Read Input Signal
5
5
Material Deformation
5
5
Electrical /Electronic Property Problem
5
5
Degraded
5
5
Smoking
5
5
Device Slipped
4
4
Device Damaged Prior to Use
4
4
Thermal Decomposition of Device
4
4
Failure to Select Signal
4
4
Excessive Heating
4
4
Corroded
4
4
Ambient Temperature Problem
4
4
Material Separation
4
4
Complete Blockage
3
3
Device Operates Differently Than Expected
3
3
Human-Device Interface Problem
3
3
Material Twisted/Bent
3
3
Physical Resistance/Sticking
3
3
Audible Prompt/Feedback Problem
3
3
No Device Output
3
3
Component Missing
3
3
Loss of or Failure to Bond
3
3
Incorrect Measurement
3
3
Low Audible Alarm
2
2
Unintended Ejection
2
2
Inaccurate Delivery
2
2
Cut In Material
2
2
Device Dislodged or Dislocated
2
2
Appropriate Term/Code Not Available
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Short Fill
2
2
Failure to Reset
2
2
Device Fell
2
2
Tear, Rip or Hole in Device Packaging
2
2
Device Stops Intermittently
2
2
Material Protrusion/Extrusion
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2432
2432
No Patient Involvement
1279
1279
No Known Impact Or Consequence To Patient
920
920
No Consequences Or Impact To Patient
319
319
Low Oxygen Saturation
178
178
Insufficient Information
80
80
Death
25
25
No Information
14
14
Hypoxia
8
8
Bradycardia
8
8
Burn(s)
8
8
Respiratory Distress
7
7
Cardiac Arrest
6
6
Partial thickness (Second Degree) Burn
6
6
Obstruction/Occlusion
6
6
Dyspnea
4
4
Viral Infection
4
4
Airway Obstruction
4
4
Tachycardia
3
3
Patient Problem/Medical Problem
3
3
Increased Respiratory Rate
2
2
No Code Available
2
2
Respiratory Arrest
2
2
Aspiration/Inhalation
2
2
Discomfort
2
2
Pneumonia
2
2
Full thickness (Third Degree) Burn
2
2
Burn, Thermal
2
2
Pressure Sores
2
2
Superficial (First Degree) Burn
1
1
Erythema
1
1
Fever
1
1
Hypothermia
1
1
Cancer
1
1
Cough
1
1
Unspecified Respiratory Problem
1
1
Blood Loss
1
1
Fibrosis
1
1
Blister
1
1
Asthma
1
1
Unspecified Infection
1
1
Pain
1
1
Complaint, Ill-Defined
1
1
Ventilator Dependent
1
1
Distress
1
1
Abrasion
1
1
Cyanosis
1
1
Low Blood Pressure/ Hypotension
1
1
Inflammation
1
1
Neurological Deficit/Dysfunction
1
1
Skin Erosion
1
1
Swelling
1
1
Respiratory Failure
1
1
Epistaxis
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Respiratory Insufficiency
1
1
Electric Shock
1
1
Stroke/CVA
1
1
Arrhythmia
1
1
Bacterial Infection
1
1
Myocardial Infarction
1
1
Virus
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hamilton Medical AG
III
Jul-14-2022
2
TELEFLEX MEDICAL INC
I
Feb-07-2020
3
Vyaire Medical
I
Jan-24-2018
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