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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
FLEXICARE MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
FOREMOUNT ENTERPRISE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
56
56
2018
53
53
2019
46
46
2020
26
26
2021
42
42
2022
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
17
17
Inflation Problem
16
16
Device Damaged Prior to Use
13
13
Defective Component
12
12
Component Missing
12
12
Defective Device
12
12
Device Operates Differently Than Expected
12
12
Appropriate Term/Code Not Available
12
12
Connection Problem
11
11
Device Issue
9
9
Device Operational Issue
9
9
Fitting Problem
8
8
Material Deformation
7
7
Detachment of Device or Device Component
6
6
Inadequacy of Device Shape and/or Size
6
6
Deflation Problem
6
6
Missing Value Reason
6
6
Loose or Intermittent Connection
5
5
Mechanical Problem
5
5
Device Dislodged or Dislocated
5
5
Gas Leak
5
5
No Flow
5
5
Disconnection
4
4
Collapse
4
4
Air Leak
4
4
Leak/Splash
4
4
Product Quality Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Insufficient Information
3
3
Physical Resistance/Sticking
3
3
Unintended Deflation
3
3
Difficult to Remove
3
3
Material Puncture/Hole
3
3
Material Separation
3
3
Detachment Of Device Component
3
3
Difficult to Open or Close
3
3
Failure to Disconnect
3
3
Separation Failure
2
2
Failure to Deliver
2
2
Structural Problem
2
2
Packaging Problem
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Integrity Problem
2
2
Material Twisted/Bent
2
2
Crack
2
2
Disassembly
2
2
Device Alarm System
2
2
Use of Device Problem
2
2
Hole In Material
2
2
Nonstandard Device
2
2
No Device Output
1
1
Increase in Pressure
1
1
Material Too Rigid or Stiff
1
1
Improper or Incorrect Procedure or Method
1
1
Suction Problem
1
1
Invalid Sensing
1
1
Shipping Damage or Problem
1
1
Unexpected Therapeutic Results
1
1
Arcing at Paddles
1
1
Complete Blockage
1
1
Failure to Deliver Energy
1
1
Fire
1
1
Fluid Leak
1
1
Melted
1
1
Misconnection
1
1
Moisture Damage
1
1
Mechanical Jam
1
1
Improper Flow or Infusion
1
1
Incorrect Device Or Component Shipped
1
1
No Pressure
1
1
Optical Distortion
1
1
Pressure Problem
1
1
Expiration Date Error
1
1
Obstruction of Flow
1
1
Incomplete or Missing Packaging
1
1
Patient-Device Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Activation, Positioning or SeparationProblem
1
1
Incomplete or Inadequate Connection
1
1
Suction Failure
1
1
Ventilation Problem in Device Environment
1
1
No Apparent Adverse Event
1
1
Patient Device Interaction Problem
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
96
96
No Consequences Or Impact To Patient
34
34
Missing Value Reason
31
31
Insufficient Information
20
20
No Clinical Signs, Symptoms or Conditions
14
14
No Patient Involvement
14
14
Low Oxygen Saturation
13
13
Death
9
9
No Code Available
9
9
Cardiac Arrest
8
8
Hypoxia
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Not Applicable
3
3
No Information
2
2
Respiratory Arrest
2
2
Loss of consciousness
2
2
Low Blood Pressure/ Hypotension
2
2
Hypoventilation
1
1
Fracture, Arm
1
1
Anemia
1
1
Burn, Thermal
1
1
Pneumothorax
1
1
Respiratory Distress
1
1
Seizures
1
1
Cardiopulmonary Arrest
1
1
Dyspnea
1
1
Endocarditis
1
1
Unspecified Tissue Injury
1
1
Asystole
1
1
Cardiovascular Insufficiency
1
1
Foreign Body In Patient
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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