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TPLC
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show TPLC since
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2014
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2020
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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
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
105
105
Break
78
78
Disconnection
36
36
Device Issue
29
29
Leak/Splash
28
28
Crack
28
28
Hole In Material
26
26
Gas/Air Leak
21
21
Split
19
19
Device Operates Differently Than Expected
19
19
Detachment of Device or Device Component
17
17
Detachment Of Device Component
16
16
Mechanical Problem
13
13
Torn Material
11
11
Connection Problem
11
11
Fracture
11
11
Fitting Problem
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
Material Puncture/Hole
5
5
Inadequacy of Device Shape and/or Size
5
5
Air Leak
5
5
Device Displays Incorrect Message
4
4
Device Handling Problem
4
4
Use of Device Problem
3
3
Defective Component
3
3
Material Too Rigid or Stiff
3
3
Device Damaged Prior to Use
3
3
Physical Property Issue
3
3
Nonstandard Device
3
3
Device Dislodged or Dislocated
3
3
Device Contamination with Chemical or Other Material
3
3
Material Separation
3
3
Failure to Deliver
2
2
Overheating of Device
2
2
Stretched
2
2
Device Slipped
2
2
Component Missing
2
2
Material Twisted/Bent
2
2
Gas Output Problem
2
2
Obstruction of Flow
2
2
Infusion or Flow Problem
2
2
Melted
2
2
Defective Device
2
2
Material Disintegration
2
2
Collapse
2
2
Material Torqued
1
1
Improper Chemical Reaction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
149
149
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
Hypoventilation
2
2
No Code Available
2
2
Pulmonary Insufficiency
2
2
Foreign Body In Patient
2
2
Hemorrhage/Bleeding
2
2
Cyanosis
1
1
Patient Problem/Medical Problem
1
1
Apnea
1
1
Death
1
1
Respiratory Distress
1
1
Not Applicable
1
1
Chest Tightness/Pressure
1
1
Cardiac Arrest
1
1
Respiratory Acidosis
1
1
Burn(s)
1
1
Rash
1
1
Injury
1
1
Erythema
1
1
Anoxia
1
1
Scar Tissue
1
1
Cough
1
1
Hypoxia
1
1
Therapeutic Effects, Unexpected
1
1
Sore Throat
1
1
Ventilator Dependent
1
1
Tissue Breakdown
1
1
Device Embedded In Tissue or Plaque
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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