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TPLC
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Device
ventilator, emergency, manual (resuscitator)
Product Code
BTM
Regulation Number
868.5915
Device Class
2
Premarket Reviews
Manufacturer
Decision
A PLUS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
AMBU A/S
SUBSTANTIALLY EQUIVALENT
2
ARCHEON
SUBSTANTIALLY EQUIVALENT
1
FLEXICARE MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
FOREMOUNT ENTERPRISE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HERSILL, S.L.
SUBSTANTIALLY EQUIVALENT
1
LAERDAL MEDICAL A/S
SUBSTANTIALLY EQUIVALENT
1
MICROBVM SYSTEMS LTD
SUBSTANTIALLY EQUIVALENT
1
NEOFORCE GROUP, INC.
SUBSTANTIALLY EQUIVALENT
1
SAFE BVM CORPORATION
SUBSTANTIALLY EQUIVALENT
1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
107
107
2015
36
36
2016
92
92
2017
56
56
2018
56
56
2019
46
46
2020
26
26
2021
42
42
2022
35
35
2023
48
48
2024
25
25
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Flow
75
75
Failure to Deliver
73
73
Break
47
47
Inflation Problem
31
31
Device Issue
31
31
Device Operates Differently Than Expected
28
28
Device Operational Issue
21
21
Separation Failure
21
21
Device Damaged Prior to Use
18
18
Defective Device
18
18
Deflation Problem
18
18
Disconnection
17
17
Connection Problem
17
17
Detachment Of Device Component
17
17
Defective Component
16
16
Difficult to Remove
16
16
Component Missing
15
15
Appropriate Term/Code Not Available
14
14
Material Integrity Problem
13
13
Gas/Air Leak
11
11
Detachment of Device or Device Component
11
11
Fitting Problem
11
11
Material Separation
10
10
Crack
10
10
Loose or Intermittent Connection
9
9
Pressure Problem
9
9
Air Leak
8
8
Missing Value Reason
8
8
Material Deformation
8
8
Device Dislodged or Dislocated
8
8
Inadequacy of Device Shape and/or Size
7
7
Use of Device Problem
7
7
Material Split, Cut or Torn
7
7
Mechanical Problem
7
7
Insufficient Information
6
6
Physical Resistance/Sticking
6
6
Therapeutic or Diagnostic Output Failure
6
6
Device Handling Problem
6
6
Activation, Positioning or Separation Problem
6
6
Hole In Material
5
5
Incomplete or Inadequate Connection
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Product Quality Problem
5
5
Torn Material
5
5
Sticking
5
5
Leak/Splash
5
5
Packaging Problem
4
4
Infusion or Flow Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Collapse
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
250
250
No Clinical Signs, Symptoms or Conditions
54
54
Missing Value Reason
54
54
No Consequences Or Impact To Patient
50
50
Low Oxygen Saturation
29
29
Insufficient Information
27
27
Not Applicable
25
25
Cardiac Arrest
24
24
No Information
22
22
No Patient Involvement
21
21
Death
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
No Code Available
12
12
Hypoxia
12
12
Respiratory Distress
6
6
Decreased Respiratory Rate
5
5
Hypoventilation
4
4
Respiratory Arrest
4
4
Respiratory Insufficiency
4
4
Bradycardia
4
4
Loss of consciousness
3
3
Cerebral Edema
2
2
Respiratory Failure
2
2
Low Blood Pressure/ Hypotension
2
2
Unspecified Respiratory Problem
2
2
Dyspnea
2
2
Cardiopulmonary Arrest
2
2
Vomiting
2
2
Foreign Body In Patient
2
2
Confusion/ Disorientation
2
2
Overdose
2
2
Brain Injury
2
2
Pneumothorax
2
2
Weakness
1
1
Loss Of Pulse
1
1
Overinflation of Lung
1
1
Pallor
1
1
Asystole
1
1
Unspecified Tissue Injury
1
1
Anemia
1
1
Hyperventilation
1
1
Therapeutic Response, Decreased
1
1
Endocarditis
1
1
Cardiovascular Insufficiency
1
1
Burn, Thermal
1
1
Obstruction/Occlusion
1
1
Diminished Pulse Pressure
1
1
Failure of Implant
1
1
Seizures
1
1
Ventilator Dependent
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Carefusion 2200 Inc
II
Aug-13-2013
2
GE Healthcare
II
Feb-03-2014
3
GE Healthcare, LLC
I
Feb-25-2014
4
GE Healthcare, LLC
I
Feb-08-2013
5
Precision Medical, Inc.
II
May-09-2010
6
Sun Med, LLC
II
Jun-09-2018
7
SunMed Holdings, LLC
II
Nov-21-2023
8
Teleflex Medical
I
Jun-24-2015
9
Unomedical
I
Nov-04-2009
10
Ventlab Corporation
I
Nov-01-2012
11
Ventlab LLC
I
Jul-03-2014
12
Vyaire Medical
I
Feb-25-2024
13
Vyaire Medical
I
Aug-08-2018
14
Westmed Inc
I
Sep-08-2010
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