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Device
ventilator, emergency, manual (resuscitator)
Regulation Description
Manual emergency ventilator.
Product Code
BTM
Regulation Number
868.5915
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMBU A/S
SUBSTANTIALLY EQUIVALENT
1
AMBU INTERNATIONAL A/S
SUBSTANTIALLY EQUIVALENT
1
FOREMOUNT ENTERPRISE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
91
91
2017
56
56
2018
53
53
2019
46
46
2020
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Issue
31
31
Break
28
28
Separation Failure
21
21
Device Operates Differently Than Expected
21
21
Device Operational Issue
19
19
Inflation Problem
16
16
Device Damaged Prior to Use
16
16
Difficult to Remove
15
15
Appropriate Term/Code Not Available
14
14
Bag
13
13
Defective Component
12
12
Connection Problem
12
12
Defective Device
11
11
Deflation Problem
9
9
Component Missing
9
9
Tube
8
8
Missing Value Reason
8
8
Fitting Problem
8
8
Valve(s)
7
7
Detachment Of Device Component
6
6
Disconnection
6
6
Material Deformation
6
6
Air Leak
6
6
Activation, Positioning or SeparationProblem
6
6
Material Separation
5
5
Crack
5
5
Device Dislodged or Dislocated
5
5
Material Integrity Problem
5
5
Inadequacy of Device Shape and/or Size
5
5
Sticking
5
5
Loose or Intermittent Connection
5
5
Kinked
4
4
Leak/Splash
4
4
Product Quality Problem
4
4
Failure to Disconnect
4
4
Manufacturing, Packaging or Shipping Problem
4
4
No Flow
4
4
Mechanical Problem
4
4
Collapse
3
3
Detachment of Device or Device Component
3
3
Torn Material
3
3
Insufficient Information
3
3
Port
3
3
Device Alarm System
2
2
Device Markings/Labelling Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Hole In Material
2
2
Packaging Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Difficult to Open or Close
2
2
Difficult to Open or Remove Packaging Material
2
2
Disassembly
2
2
Incomplete or Missing Packaging
2
2
Failure to Deliver
2
2
Melted
2
2
Bent
2
2
Seal
1
1
Arcing at Paddles
1
1
Valve, Flap
1
1
Heads
1
1
Ring
1
1
Nonstandard Device
1
1
Material Puncture/Hole
1
1
Complete Blockage
1
1
Structural Problem
1
1
Expiration Date Error
1
1
Fire
1
1
Shipping Damage or Problem
1
1
Patient-Device Incompatibility
1
1
No Apparent Adverse Event
1
1
Gas Leak
1
1
Improper Flow or Infusion
1
1
Mechanical Jam
1
1
Patient Device Interaction Problem
1
1
Material Split, Cut or Torn
1
1
No Pressure
1
1
Optical Distortion
1
1
Pressure Problem
1
1
Ventilation Problem in Device Environment
1
1
Device Subassembly
1
1
Incomplete or Inadequate Connection
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Incorrect Device Or Component Shipped
1
1
Device Displays Incorrect Message
1
1
Invalid Sensing
1
1
Failure To Adhere Or Bond
1
1
Restricted Flow rate
1
1
Connector
1
1
Label
1
1
Improper or Incorrect Procedure or Method
1
1
Misconnection
1
1
Moisture Damage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
147
147
Missing Value Reason
54
54
No Consequences Or Impact To Patient
40
40
Not Applicable
25
25
No Patient Involvement
18
18
No Information
14
14
Death
12
12
No Code Available
10
10
Low Oxygen Saturation
7
7
Hypoxia
5
5
Cardiac Arrest
3
3
Low Blood Pressure/ Hypotension
2
2
Hypoventilation
1
1
Cardiopulmonary Arrest
1
1
Dyspnea
1
1
Fracture, Arm
1
1
Insufficient Information
1
1
Respiratory Distress
1
1
Seizures
1
1
Brain Injury
1
1
Burn, Thermal
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sun Med, LLC
II
Jun-09-2018
2
Vyaire Medical
I
Aug-08-2018
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