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TPLC
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Device
mixer, breathing gases, anesthesia inhalation
Regulation Description
Breathing gas mixer.
Product Code
BZR
Regulation Number
868.5330
Device Class
2
Premarket Reviews
Manufacturer
Decision
BALDUS SEDATION GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
2
1. K222794
FlowStar Touch Digital Mixer Flowmeter
2. K230987
FlowStar Analog Mixer Flowmeter
DEHAS MEDICAL SYSTEMS GMBH
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
1
PARKER HANNIFIN
SUBSTANTIALLY EQUIVALENT
1
PARKER HANNIFIN CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
15
15
2021
33
33
2022
15
15
2023
19
19
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
34
34
Leak/Splash
8
8
No Audible Alarm
5
5
Output Problem
4
4
Fire
3
3
Device Alarm System
3
3
Therapeutic or Diagnostic Output Failure
3
3
Gas Output Problem
3
3
Contamination
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Gas/Air Leak
2
2
Inaccurate Delivery
2
2
Protective Measures Problem
2
2
No Flow
2
2
Defective Device
2
2
Appropriate Term/Code Not Available
2
2
Device Contamination with Body Fluid
1
1
Material Frayed
1
1
Device Damaged by Another Device
1
1
Failure to Deliver
1
1
Improper or Incorrect Procedure or Method
1
1
Positioning Problem
1
1
Infusion or Flow Problem
1
1
Improper Flow or Infusion
1
1
Medical Gas Supply Problem
1
1
No Audible Prompt/Feedback
1
1
Device Handling Problem
1
1
Melted
1
1
Pressure Problem
1
1
Volume Accuracy Problem
1
1
Display or Visual Feedback Problem
1
1
High Readings
1
1
Crack
1
1
Output above Specifications
1
1
Failure to Align
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
No Display/Image
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
71
71
Low Oxygen Saturation
12
12
Insufficient Information
8
8
No Information
3
3
No Patient Involvement
2
2
No Consequences Or Impact To Patient
2
2
Superficial (First Degree) Burn
1
1
Respiratory Arrest
1
1
Hypoxia
1
1
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