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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
248
248
2022
335
335
2023
1236
1236
2024
151
151
Device Problems
MDRs with this Device Problem
Events in those MDRs
Protective Measures Problem
998
998
Battery Problem
432
432
Electrical /Electronic Property Problem
162
162
Inadequate User Interface
148
148
Failure of Device to Self-Test
123
123
Device Displays Incorrect Message
120
120
Failure to Calibrate
112
112
Failure to Charge
102
102
Power Problem
75
75
Inappropriate Tactile Prompt/Feedback
69
69
Failure to Power Up
68
68
Unexpected Shutdown
54
54
Complete Loss of Power
45
45
Charging Problem
35
35
Degraded
24
24
Therapeutic or Diagnostic Output Failure
24
24
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
12
12
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
Insufficient Information
8
8
No Audible Alarm
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
Temperature Problem
3
3
Noise, Audible
2
2
Moisture or Humidity Problem
2
2
Alarm Not Visible
2
2
False Alarm
2
2
Defective Alarm
2
2
Device Emits Odor
2
2
Image Display Error/Artifact
2
2
Leak/Splash
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
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
Energy Output Problem
1
1
Accessory Incompatible
1
1
Use of Incorrect Control/Treatment Settings
1
1
Disconnection
1
1
Problem with Software Installation
1
1
No Visual Prompts/Feedback
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1767
1767
No Consequences Or Impact To Patient
181
181
Insufficient Information
74
74
No Patient Involvement
16
16
Low Oxygen Saturation
11
11
Death
7
7
Cardiac Arrest
6
6
Respiratory Arrest
6
6
Aspiration/Inhalation
4
4
Loss of consciousness
3
3
Diaphoresis
3
3
Dyspnea
3
3
Respiratory Insufficiency
3
3
No Known Impact Or Consequence To Patient
3
3
Swelling/ Edema
2
2
Unspecified Infection
2
2
Respiratory Failure
2
2
Pneumonia
2
2
Discomfort
2
2
Abdominal Distention
1
1
Pain
1
1
Cardiopulmonary Arrest
1
1
Eye Injury
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoxia
1
1
No Information
1
1
Cancer
1
1
Blister
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
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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