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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
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Flow
75
75
Failure to Deliver
73
73
Break
46
46
Inflation Problem
31
31
Device Issue
31
31
Device Operates Differently Than Expected
28
28
Device Operational Issue
21
21
Separation Failure
21
21
Defective Device
18
18
Device Damaged Prior to Use
18
18
Deflation Problem
18
18
Detachment Of Device Component
17
17
Disconnection
17
17
Connection Problem
17
17
Defective Component
16
16
Difficult to Remove
16
16
Component Missing
15
15
Appropriate Term/Code Not Available
14
14
Detachment of Device or Device Component
11
11
Gas/Air Leak
11
11
Material Integrity Problem
11
11
Fitting Problem
11
11
Material Separation
9
9
Loose or Intermittent Connection
9
9
Pressure Problem
9
9
Material Deformation
8
8
Device Dislodged or Dislocated
8
8
Missing Value Reason
8
8
Crack
8
8
Air Leak
8
8
Inadequacy of Device Shape and/or Size
7
7
Use of Device Problem
7
7
Mechanical Problem
6
6
Device Handling Problem
6
6
Physical Resistance/Sticking
6
6
Activation, Positioning or Separation Problem
6
6
Insufficient Information
6
6
Therapeutic or Diagnostic Output Failure
6
6
Torn Material
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Incomplete or Inadequate Connection
5
5
Material Split, Cut or Torn
5
5
Hole In Material
5
5
Sticking
5
5
Product Quality Problem
5
5
Leak/Splash
5
5
Kinked
4
4
Collapse
4
4
Unintended Deflation
4
4
Infusion or Flow Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Packaging Problem
4
4
Failure to Disconnect
4
4
Difficult to Open or Close
4
4
Device Markings/Labelling Problem
3
3
Improper Flow or Infusion
3
3
Complete Blockage
3
3
Device Alarm System
3
3
Component Falling
3
3
Fluid/Blood Leak
3
3
Material Puncture/Hole
3
3
Improper or Incorrect Procedure or Method
3
3
Tear, Rip or Hole in Device Packaging
3
3
Incomplete or Missing Packaging
2
2
Device Displays Incorrect Message
2
2
Structural Problem
2
2
Decrease in Pressure
2
2
Increase in Pressure
2
2
Imprecision
2
2
Disassembly
2
2
Melted
2
2
Misconnection
2
2
Nonstandard Device
2
2
Bent
2
2
Improper Device Output
2
2
Device Contamination with Chemical or Other Material
2
2
Difficult to Open or Remove Packaging Material
2
2
Output Problem
2
2
Ventilation Problem in Device Environment
2
2
Material Twisted/Bent
2
2
Mechanical Jam
1
1
No Pressure
1
1
Optical Distortion
1
1
Output below Specifications
1
1
No Apparent Adverse Event
1
1
Delivery System Failure
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Incorrect Device Or Component Shipped
1
1
Failure to Seal
1
1
Suction Failure
1
1
Premature Separation
1
1
Missing Information
1
1
Activation Failure
1
1
Patient Device Interaction Problem
1
1
Failure To Adhere Or Bond
1
1
Arcing at Paddles
1
1
Contamination
1
1
Decoupling
1
1
Failure to Deliver Energy
1
1
Fire
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
250
250
Missing Value Reason
54
54
No Consequences Or Impact To Patient
50
50
No Clinical Signs, Symptoms or Conditions
46
46
Low Oxygen Saturation
29
29
Insufficient Information
25
25
Not Applicable
25
25
No Information
22
22
No Patient Involvement
21
21
Cardiac Arrest
20
20
Death
19
19
No Code Available
12
12
Hypoxia
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Respiratory Distress
6
6
Decreased Respiratory Rate
5
5
Respiratory Arrest
4
4
Bradycardia
4
4
Hypoventilation
4
4
Respiratory Insufficiency
4
4
Loss of consciousness
3
3
Low Blood Pressure/ Hypotension
2
2
Respiratory Failure
2
2
Dyspnea
2
2
Overdose
2
2
Pneumothorax
2
2
Vomiting
2
2
Cardiopulmonary Arrest
2
2
Confusion/ Disorientation
2
2
Foreign Body In Patient
2
2
Brain Injury
2
2
Unspecified Respiratory Problem
2
2
Cerebral Edema
2
2
Hyperventilation
1
1
Weakness
1
1
Complaint, Ill-Defined
1
1
Seizures
1
1
Ventilator Dependent
1
1
Failure of Implant
1
1
Anemia
1
1
Diminished Pulse Pressure
1
1
Unspecified Tissue Injury
1
1
Asystole
1
1
Pallor
1
1
Endocarditis
1
1
Fracture, Arm
1
1
Overinflation of Lung
1
1
Burn, Thermal
1
1
Loss Of Pulse
1
1
Cardiovascular Insufficiency
1
1
Therapeutic Response, Decreased
1
1
Obstruction/Occlusion
1
1
Bronchitis
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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