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TPLC
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show TPLC since
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Device
ventilator, emergency, powered (resuscitator)
Product Code
BTL
Regulation Number
868.5925
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALLIED HEALTHCARE PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
5
ATOM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
AUTOMEDX INC.
SUBSTANTIALLY EQUIVALENT
1
DOLPHYS MEDICAL B.V.
SUBSTANTIALLY EQUIVALENT
1
INTERNATIONAL BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
2
MAGNAMED TECNOLOGIA MEDICA S/A
SUBSTANTIALLY EQUIVALENT
1
MERCURY MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MERCURY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
NEOFORCE GROUP, INC.
SUBSTANTIALLY EQUIVALENT
1
O-TWO MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
3
SMITHS MEDICAL INTERNATIONAL LTD.
SUBSTANTIALLY EQUIVALENT
1
THORNHILL RESEARCH INC
SUBSTANTIALLY EQUIVALENT
2
THORNHILL RESEARCH INC.
SUBSTANTIALLY EQUIVALENT
1
VBM MEDIZINTECHNIK GMBH
SUBSTANTIALLY EQUIVALENT
1
VENTLAB, LLC
SUBSTANTIALLY EQUIVALENT
1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
SUBSTANTIALLY EQUIVALENT
2
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH + CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
69
69
2015
79
79
2016
80
80
2017
101
101
2018
197
197
2019
341
341
2020
454
454
2021
506
506
2022
755
755
2023
787
787
2024
523
523
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
791
791
Pressure Problem
736
736
Device Alarm System
275
275
Failure to Cycle
210
210
Tidal Volume Fluctuations
143
143
Mechanical Problem
139
139
Defective Component
125
125
Gas/Air Leak
124
124
Loose or Intermittent Connection
97
97
Component Missing
95
95
No Audible Alarm
83
83
Detachment of Device or Device Component
82
82
Defective Device
78
78
Device Issue
75
75
Defective Alarm
73
73
Output Problem
73
73
Battery Problem
70
70
Noise, Audible
68
68
Crack
68
68
Incorrect, Inadequate or Imprecise Result or Readings
60
60
Fracture
54
54
Leak/Splash
51
51
Infusion or Flow Problem
48
48
Power Problem
46
46
Connection Problem
43
43
Failure to Power Up
40
40
Device Operates Differently Than Expected
38
38
Calibration Problem
37
37
Insufficient Information
36
36
Increase in Pressure
35
35
Failure to Deliver
34
34
Decrease in Pressure
33
33
Improper Flow or Infusion
32
32
Device Handling Problem
32
32
Unable to Obtain Readings
31
31
Device Fell
29
29
No Flow
28
28
Physical Resistance/Sticking
27
27
Display or Visual Feedback Problem
27
27
Key or Button Unresponsive/not Working
27
27
Gas Output Problem
26
26
Electrical /Electronic Property Problem
25
25
Therapeutic or Diagnostic Output Failure
25
25
Device Damaged Prior to Use
21
21
Volume Accuracy Problem
20
20
Device Difficult to Maintain
19
19
No Pressure
19
19
Disconnection
19
19
Inaccurate Flow Rate
18
18
Device Sensing Problem
18
18
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2200
2200
Insufficient Information
546
546
No Patient Involvement
421
421
No Known Impact Or Consequence To Patient
392
392
No Information
276
276
No Consequences Or Impact To Patient
215
215
Low Oxygen Saturation
24
24
Hypoventilation
11
11
Death
10
10
Patient Problem/Medical Problem
9
9
Cardiac Arrest
9
9
Apnea
6
6
Not Applicable
6
6
Hypoxia
6
6
Pneumothorax
4
4
Respiratory Distress
4
4
Respiratory Arrest
4
4
Bradycardia
4
4
Decreased Respiratory Rate
3
3
Low Blood Pressure/ Hypotension
3
3
Cardiopulmonary Arrest
3
3
Ventilator Dependent
2
2
Respiratory Failure
2
2
Complaint, Ill-Defined
2
2
Respiratory Insufficiency
2
2
Respiratory Distress Syndrome of Newborns
2
2
Hyperventilation
2
2
Asphyxia
2
2
Distress
1
1
Airway Obstruction
1
1
Inadequate Pain Relief
1
1
Bacterial Infection
1
1
Unspecified Respiratory Problem
1
1
Anxiety
1
1
Missing Value Reason
1
1
Overinflation of Lung
1
1
Respiratory Tract Infection
1
1
Loss Of Pulse
1
1
Paralysis
1
1
Unspecified Blood or Lymphatic problem
1
1
Respiratory Acidosis
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Low Cardiac Output
1
1
Asthma
1
1
Resuscitation
1
1
Pleural Empyema
1
1
Ischemia
1
1
Diminished Pulse Pressure
1
1
Sepsis
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical Systems, Inc.
I
Apr-10-2014
2
GE Healthcare
II
Feb-03-2014
3
GE Healthcare, LLC
I
Feb-25-2014
4
GE Healthcare, LLC
I
Feb-08-2013
5
GE Healthcare, LLC
I
Dec-26-2012
6
Impact Instrumentation, Inc.
II
Jun-26-2015
7
Instrumentation Industries Inc
II
Apr-16-2013
8
Mercury Enterprises, Inc. dba Mercury Medical
II
Jan-12-2016
9
O-Two Medical Technologies, Inc.
I
Apr-04-2019
10
Precision Valve & Automation,Inc
II
Aug-14-2020
11
Smiths Medical ASD Inc.
I
Sep-20-2024
12
Smiths Medical ASD Inc.
I
Sep-11-2024
13
Smiths Medical ASD Inc.
I
Mar-19-2024
14
Smiths Medical ASD Inc.
III
Oct-22-2021
15
Thornhill Research Inc
I
Jan-11-2016
16
Vortran Medical Technology 1, Inc
II
Apr-25-2017
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