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TPLC
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show TPLC since
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2024
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Device
mixer, breathing gases, anesthesia inhalation
Product Code
BZR
Regulation Number
868.5330
Device Class
2
Premarket Reviews
Manufacturer
Decision
ATOM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BALDUS SEDATION GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
2
CARDINAL HEALTH 207, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K092484
HELIOX LOW FLOW SENTRY BLENDER
DEHAS MEDICAL SYSTEMS GMBH
SUBSTANTIALLY EQUIVALENT
1
GENTEC (SHANGHAI) CORPORATION
SUBSTANTIALLY EQUIVALENT
1
LINDE HEALTHCARE AB
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, INC.
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
2
O-TWO MEDICAL TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
O-TWO MEDICAL TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
PARKER HANNIFIN
SUBSTANTIALLY EQUIVALENT
1
PRECISION MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
39
39
2016
30
30
2017
22
22
2018
24
24
2019
26
26
2020
15
15
2021
33
33
2022
15
15
2023
19
19
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
39
39
Inaccurate Delivery
32
32
Device Operates Differently Than Expected
29
29
No Audible Alarm
21
21
Device Alarm System
17
17
Leak/Splash
17
17
Output Problem
8
8
Infusion or Flow Problem
7
7
Out-Of-Box Failure
6
6
Defective Device
5
5
Fire
5
5
Therapeutic or Diagnostic Output Failure
5
5
No Apparent Adverse Event
4
4
Material Integrity Problem
4
4
Improper Device Output
4
4
No Flow
4
4
Gas Output Problem
4
4
Calibration Problem
4
4
Failure to Calibrate
4
4
Loose or Intermittent Connection
3
3
False Alarm
3
3
Gas/Air Leak
3
3
Medical Gas Supply Problem
3
3
Protective Measures Problem
3
3
Insufficient Information
2
2
Appropriate Term/Code Not Available
2
2
Positioning Problem
2
2
Pressure Problem
2
2
Improper Flow or Infusion
2
2
Contamination
2
2
Excess Flow or Over-Infusion
2
2
High Readings
2
2
Delayed Alarm
2
2
Failure to Deliver
2
2
Output above Specifications
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Device Slipped
1
1
Volume Accuracy Problem
1
1
Insufficient Flow or Under Infusion
1
1
No Audible Prompt/Feedback
1
1
No Device Output
1
1
Device Displays Incorrect Message
1
1
Failure to Align
1
1
Incorrect Or Inadequate Test Results
1
1
Kinked
1
1
Material Frayed
1
1
Incorrect Measurement
1
1
Melted
1
1
Misconnection
1
1
Use of Incorrect Control/Treatment Settings
1
1
Crack
1
1
Disconnection
1
1
Display or Visual Feedback Problem
1
1
Defective Alarm
1
1
Break
1
1
Material Twisted/Bent
1
1
Device Damaged by Another Device
1
1
Device Sensing Problem
1
1
Free or Unrestricted Flow
1
1
Programming Issue
1
1
Naturally Worn
1
1
Misassembly During Maintenance/Repair
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
99
99
No Clinical Signs, Symptoms or Conditions
65
65
Low Oxygen Saturation
24
24
No Known Impact Or Consequence To Patient
20
20
No Consequences Or Impact To Patient
11
11
Insufficient Information
8
8
No Information
7
7
Superficial (First Degree) Burn
2
2
Respiratory Distress
2
2
Retinal Injury
1
1
Complaint, Ill-Defined
1
1
Abnormal Blood Gases
1
1
Death
1
1
Hypoxia
1
1
Overdose
1
1
High Oxygen Saturation
1
1
Abdominal Distention
1
1
No Code Available
1
1
Respiratory Arrest
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CAREstream Medical LLC
II
Aug-22-2018
2
O-Two Medical Technologies, Inc.
II
Aug-22-2018
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