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TPLC
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Device
continuous, ventilator, home use
Definition
This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
Product Code
NOU
Regulation Number
868.5895
Device Class
2
Premarket Reviews
Manufacturer
Decision
BREAS MEDICAL AB
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
37
37
2020
67
67
2021
246
246
2022
335
335
2023
1234
1234
2024
88
88
Device Problems
MDRs with this Device Problem
Events in those MDRs
Protective Measures Problem
957
957
Battery Problem
432
432
Electrical /Electronic Property Problem
162
162
Inadequate User Interface
132
132
Failure of Device to Self-Test
123
123
Device Displays Incorrect Message
120
120
Failure to Calibrate
112
112
Failure to Charge
100
100
Power Problem
75
75
Inappropriate Tactile Prompt/Feedback
69
69
Failure to Power Up
66
66
Unexpected Shutdown
52
52
Complete Loss of Power
43
43
Charging Problem
33
33
Degraded
24
24
Therapeutic or Diagnostic Output Failure
22
22
Premature Discharge of Battery
20
20
Device Alarm System
18
18
Unexpected Therapeutic Results
17
17
Display or Visual Feedback Problem
15
15
Output Problem
13
13
Key or Button Unresponsive/not Working
12
12
Adverse Event Without Identified Device or Use Problem
11
11
Pressure Problem
10
10
No Tactile Prompts/Feedback
9
9
Inappropriate or Unexpected Reset
9
9
Circuit Failure
9
9
Capacitative Coupling
9
9
Operating System Becomes Nonfunctional
8
8
No Audible Alarm
7
7
Insufficient Information
7
7
Mechanical Problem
6
6
Nonstandard Device
5
5
No Display/Image
5
5
Intermittent Loss of Power
5
5
Application Program Freezes, Becomes Nonfunctional
4
4
Contamination
4
4
Moisture Damage
4
4
Failure to Run on Battery
4
4
Defective Component
4
4
Human-Device Interface Problem
3
3
Overheating of Device
3
3
Particulates
3
3
Break
3
3
Alarm Not Visible
2
2
False Alarm
2
2
Defective Alarm
2
2
Device Emits Odor
2
2
Image Display Error/Artifact
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Device Sensing Problem
2
2
Difficult to Open or Close
2
2
Detachment of Device or Device Component
2
2
Insufficient Flow or Under Infusion
2
2
Contamination /Decontamination Problem
2
2
Patient-Device Incompatibility
2
2
Noise, Audible
2
2
Temperature Problem
2
2
Moisture or Humidity Problem
2
2
Problem with Software Installation
1
1
No Visual Prompts/Feedback
1
1
Ambient Temperature Problem
1
1
Defective Device
1
1
Communication or Transmission Problem
1
1
Connection Problem
1
1
No Audible Prompt/Feedback
1
1
Inaccurate Delivery
1
1
Tidal Volume Fluctuations
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Device Markings/Labelling Problem
1
1
Calibration Problem
1
1
Electrical Power Problem
1
1
Failure to Shut Off
1
1
Gas/Air Leak
1
1
Improper Flow or Infusion
1
1
Battery Problem: Low Impedance
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Mechanics Altered
1
1
Self-Activation or Keying
1
1
Failure to Read Input Signal
1
1
Smoking
1
1
Loss of Power
1
1
Unable to Obtain Readings
1
1
Leak/Splash
1
1
Energy Output Problem
1
1
Accessory Incompatible
1
1
Use of Incorrect Control/Treatment Settings
1
1
Disconnection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1703
1703
No Consequences Or Impact To Patient
181
181
Insufficient Information
72
72
No Patient Involvement
16
16
Low Oxygen Saturation
11
11
Death
7
7
Respiratory Arrest
4
4
Aspiration/Inhalation
4
4
Cardiac Arrest
4
4
Dyspnea
3
3
Loss of consciousness
3
3
Diaphoresis
3
3
Respiratory Insufficiency
3
3
No Known Impact Or Consequence To Patient
3
3
Swelling/ Edema
2
2
Respiratory Failure
2
2
Unspecified Infection
2
2
Blister
1
1
Pain
1
1
Pneumonia
1
1
Cardiopulmonary Arrest
1
1
Cancer
1
1
Abdominal Distention
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoxia
1
1
No Information
1
1
Eye Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Breas Medical, Inc.
II
Nov-27-2023
2
Breas Medical, Inc.
II
Jul-13-2022
3
Breas Medical, Inc.
II
Feb-24-2020
4
Philips Respironics, Inc.
II
Aug-13-2021
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