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TPLC
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Device
ventilator, emergency, powered (resuscitator)
Regulation Description
Powered emergency ventilator.
Product Code
BTL
Regulation Number
868.5925
Device Class
2
Premarket Reviews
Manufacturer
Decision
MAGNAMED TECNOLOGIA MEDICA S/A
SUBSTANTIALLY EQUIVALENT
1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
SUBSTANTIALLY EQUIVALENT
1
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH + CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
454
454
2021
506
506
2022
755
755
2023
731
731
2024
667
667
2025
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Pressure Problem
641
641
Break
554
554
Device Alarm System
234
234
Failure to Cycle
193
193
Gas/Air Leak
139
139
Mechanical Problem
123
123
Tidal Volume Fluctuations
101
101
Defective Component
95
95
Loose or Intermittent Connection
95
95
Detachment of Device or Device Component
81
81
Defective Device
75
75
Component Missing
66
66
No Audible Alarm
62
62
Defective Alarm
60
60
Battery Problem
57
57
Crack
54
54
Incorrect, Inadequate or Imprecise Result or Readings
53
53
Fracture
52
52
Noise, Audible
47
47
Inaccurate Delivery
45
45
Output Problem
40
40
Insufficient Information
39
39
Power Problem
38
38
Leak/Splash
37
37
Connection Problem
35
35
Failure to Power Up
35
35
Unable to Obtain Readings
28
28
Infusion or Flow Problem
27
27
Improper Flow or Infusion
27
27
Key or Button Unresponsive/not Working
27
27
Increase in Pressure
26
26
Device Fell
25
25
Failure to Deliver
25
25
Display or Visual Feedback Problem
24
24
Calibration Problem
24
24
Decrease in Pressure
22
22
Gas Output Problem
22
22
Volume Accuracy Problem
21
21
No Flow
21
21
Therapeutic or Diagnostic Output Failure
20
20
Inaccurate Flow Rate
19
19
Electrical /Electronic Property Problem
19
19
Device Difficult to Maintain
19
19
Device Damaged Prior to Use
17
17
Physical Resistance/Sticking
16
16
Disconnection
16
16
No Pressure
16
16
Device Sensing Problem
15
15
Failure of Device to Self-Test
14
14
Free or Unrestricted Flow
13
13
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2311
2311
Insufficient Information
556
556
No Information
181
181
No Patient Involvement
164
164
No Consequences Or Impact To Patient
90
90
No Known Impact Or Consequence To Patient
44
44
Low Oxygen Saturation
12
12
Hypoventilation
7
7
Cardiac Arrest
5
5
Respiratory Arrest
4
4
Pneumothorax
4
4
Hypoxia
4
4
Decreased Respiratory Rate
2
2
Bradycardia
2
2
Ventilator Dependent
2
2
Respiratory Insufficiency
2
2
Sepsis
1
1
Respiratory Failure
1
1
Respiratory Distress Syndrome of Newborns
1
1
Apnea
1
1
Ischemia
1
1
Cyanosis
1
1
Asthma
1
1
Pleural Empyema
1
1
Airway Obstruction
1
1
Patient Problem/Medical Problem
1
1
Unspecified Blood or Lymphatic problem
1
1
Pulmonary Hypertension
1
1
Low Cardiac Output
1
1
Overinflation of Lung
1
1
Air Embolism
1
1
Hyperventilation
1
1
Sleep Dysfunction
1
1
Respiratory Distress
1
1
Unspecified Respiratory Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mercury Enterprises, Inc. dba Mercury Medical
I
Jan-10-2025
2
Mercury Enterprises, Inc. dba Mercury Medical
I
Oct-02-2024
3
Precision Valve & Automation,Inc
II
Aug-14-2020
4
Smiths Medical ASD Inc.
I
Sep-20-2024
5
Smiths Medical ASD Inc.
I
Sep-11-2024
6
Smiths Medical ASD Inc.
I
Mar-19-2024
7
Smiths Medical ASD Inc.
III
Oct-22-2021
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