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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
ARCHEON
SUBSTANTIALLY EQUIVALENT
1
SAFE BVM CORPORATION
SUBSTANTIALLY EQUIVALENT
1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
46
46
2020
26
26
2021
42
42
2022
35
35
2023
48
48
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inflation Problem
19
19
Break
17
17
Defective Device
13
13
Defective Component
11
11
Deflation Problem
10
10
Detachment of Device or Device Component
10
10
Gas/Air Leak
10
10
Pressure Problem
9
9
Device Damaged Prior to Use
9
9
Connection Problem
7
7
Component Missing
7
7
Physical Resistance/Sticking
6
6
Incomplete or Inadequate Connection
5
5
Material Integrity Problem
5
5
No Flow
4
4
Difficult to Open or Close
4
4
Therapeutic or Diagnostic Output Failure
4
4
Unintended Deflation
4
4
Material Split, Cut or Torn
4
4
Failure to Deliver
4
4
Loose or Intermittent Connection
4
4
Material Puncture/Hole
3
3
Mechanical Problem
3
3
Disconnection
3
3
Crack
3
3
Fluid/Blood Leak
3
3
Fitting Problem
3
3
Use of Device Problem
3
3
Material Deformation
3
3
Packaging Problem
2
2
Material Twisted/Bent
2
2
Infusion or Flow Problem
2
2
Device Handling Problem
2
2
Material Separation
2
2
Inadequacy of Device Shape and/or Size
2
2
Tear, Rip or Hole in Device Packaging
2
2
Failure to Disconnect
2
2
Activation, Positioning or Separation Problem
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Expiration Date Error
1
1
Unexpected Therapeutic Results
1
1
Improper or Incorrect Procedure or Method
1
1
Suction Problem
1
1
Incomplete or Missing Packaging
1
1
Device Alarm System
1
1
Complete Blockage
1
1
Collapse
1
1
Failure to Deliver Energy
1
1
Leak/Splash
1
1
Misconnection
1
1
Moisture Damage
1
1
Nonstandard Device
1
1
No Device Output
1
1
Increase in Pressure
1
1
Product Quality Problem
1
1
Material Too Rigid or Stiff
1
1
Incorrect Measurement
1
1
Patient Device Interaction Problem
1
1
Failure to Seal
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Suction Failure
1
1
Premature Separation
1
1
Missing Information
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Improper Flow or Infusion
1
1
Device Dislodged or Dislocated
1
1
Device Markings/Labelling Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Mechanical Jam
1
1
No Pressure
1
1
Optical Distortion
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
44
44
No Known Impact Or Consequence To Patient
36
36
Insufficient Information
25
25
Low Oxygen Saturation
18
18
No Consequences Or Impact To Patient
15
15
Cardiac Arrest
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
No Patient Involvement
10
10
Decreased Respiratory Rate
5
5
Respiratory Arrest
4
4
Respiratory Insufficiency
4
4
Death
4
4
Hypoxia
4
4
Loss of consciousness
3
3
Respiratory Failure
2
2
Bradycardia
2
2
Hypoventilation
2
2
Vomiting
2
2
Unspecified Respiratory Problem
2
2
Cerebral Edema
2
2
No Code Available
2
2
Missing Value Reason
1
1
No Information
1
1
Diminished Pulse Pressure
1
1
Foreign Body In Patient
1
1
Asystole
1
1
Cardiovascular Insufficiency
1
1
Unspecified Tissue Injury
1
1
Anemia
1
1
Failure of Implant
1
1
Pneumothorax
1
1
Respiratory Distress
1
1
Dyspnea
1
1
Endocarditis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
SunMed Holdings, LLC
II
Nov-21-2023
2
Vyaire Medical
I
Feb-25-2024
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