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TPLC
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show TPLC since
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2024
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Device
set, tubing and support, ventilator (w harness)
Product Code
BZO
Regulation Number
868.5975
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
84
84
2015
55
55
2016
56
56
2017
46
46
2018
26
26
2019
33
33
2020
30
30
2021
52
52
2022
66
66
2023
37
37
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
101
101
Break
77
77
Disconnection
36
36
Device Issue
29
29
Crack
28
28
Leak/Splash
28
28
Hole In Material
26
26
Gas/Air Leak
20
20
Split
19
19
Device Operates Differently Than Expected
19
19
Detachment of Device or Device Component
16
16
Detachment Of Device Component
16
16
Mechanical Problem
13
13
Torn Material
11
11
Connection Problem
10
10
Fitting Problem
10
10
Fracture
10
10
Failure of Device to Self-Test
9
9
Material Integrity Problem
8
8
Loose or Intermittent Connection
7
7
Insufficient Information
6
6
Inadequacy of Device Shape and/or Size
5
5
Material Puncture/Hole
5
5
Air Leak
5
5
Device Displays Incorrect Message
4
4
Device Handling Problem
4
4
Physical Property Issue
3
3
Device Contamination with Chemical or Other Material
3
3
Device Dislodged or Dislocated
3
3
Use of Device Problem
3
3
Material Too Rigid or Stiff
3
3
Material Separation
3
3
Device Damaged Prior to Use
3
3
Defective Component
3
3
Nonstandard Device
3
3
Gas Output Problem
2
2
Overheating of Device
2
2
Melted
2
2
Component Missing
2
2
Collapse
2
2
Material Disintegration
2
2
Obstruction of Flow
2
2
Defective Device
2
2
Device Slipped
2
2
Stretched
2
2
Infusion or Flow Problem
2
2
Material Twisted/Bent
2
2
Mechanics Altered
1
1
No Flow
1
1
Adverse Event Without Identified Device or Use Problem
1
1
No Pressure
1
1
Packaging Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Improper Chemical Reaction
1
1
Improper Flow or Infusion
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Torqued
1
1
Misassembly by Users
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient-Device Incompatibility
1
1
Contamination /Decontamination Problem
1
1
Material Fragmentation
1
1
Kinked
1
1
Failure To Adhere Or Bond
1
1
Bent
1
1
Partial Blockage
1
1
Component Falling
1
1
Thermal Decomposition of Device
1
1
Circuit Failure
1
1
Out-Of-Box Failure
1
1
Failure to Deliver
1
1
Shipping Damage or Problem
1
1
Occlusion Within Device
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Suction Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
142
142
No Patient Involvement
112
112
No Consequences Or Impact To Patient
101
101
No Known Impact Or Consequence To Patient
95
95
Low Oxygen Saturation
19
19
Insufficient Information
13
13
No Information
6
6
Bradycardia
6
6
Decreased Respiratory Rate
4
4
Skin Erosion
3
3
Foreign Body In Patient
2
2
No Code Available
2
2
Hemorrhage/Bleeding
2
2
Hypoventilation
2
2
Pulmonary Insufficiency
2
2
Rash
1
1
Respiratory Distress
1
1
Scar Tissue
1
1
Injury
1
1
Ventilator Dependent
1
1
Sore Throat
1
1
Chest Tightness/Pressure
1
1
Hypoxia
1
1
Anoxia
1
1
Apnea
1
1
Burn(s)
1
1
Cardiac Arrest
1
1
Cyanosis
1
1
Death
1
1
Erythema
1
1
Cough
1
1
Device Embedded In Tissue or Plaque
1
1
Not Applicable
1
1
Patient Problem/Medical Problem
1
1
Tissue Breakdown
1
1
Therapeutic Effects, Unexpected
1
1
Respiratory Acidosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical, Inc.
I
May-17-2023
2
Draeger Medical, Inc.
II
Apr-10-2014
3
Fisher & Paykel Healthcare, Ltd.
I
May-20-2014
4
Fisher & Paykel Healthcare, Ltd.
I
Jan-03-2013
5
Hamilton Medical, Inc.
II
Jul-02-2015
6
Mallinckrodt Manufacturing LLC
I
Sep-09-2023
7
TELEFLEX MEDICAL INC
II
May-24-2022
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