Gas-machine, Anesthesia

Device Code: 14

Product Code(s): BSZ

Device Classification Information

Device Type ID14
Device NameGas-machine, Anesthesia
Regulation DescriptionGas Machine For Anesthesia Or Analgesia.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(k)
CFR Regulation Number868.5160 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeBSZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID14
DeviceGas-machine, Anesthesia
Product CodeBSZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGas Machine For Anesthesia Or Analgesia.
CFR Regulation Number868.5160 [🔎]
Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
DRAEGER MEDICAL GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
DRE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MAQUET CRITICAL CARE AB
 
SUBSTANTIALLY EQUIVALENT
 2
MAQUET, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
ORICARE, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
THORNHILL RESEARCH INCORPORATED
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Device Operates Differently Than Expected
 1423
Appropriate Term/Code Not Available
 1184
Device Alarm System
 618
Device Displays Incorrect Message
469
Leak / Splash
 392
Mechanical Problem
 335
Output Problem
 335
Pressure Problem
 272
Suction Problem
 226
Device Inoperable
 209
Break
 169
Tidal Volume Fluctuations
 161
Excess Flow Or Over-Infusion
 118
Mechanical Jam
 107
Energy Output Problem
91
Therapeutic Or Diagnostic Output Failure
 82
No Display / Image
 74
Unexpected Therapeutic Results
73
Sticking
 67
Gas Leak
 60
High Readings
 58
Infusion Or Flow Problem
 53
Increase In Pressure
 41
Battery Problem
 28
Physical Resistance / Sticking
 27
Inappropriate Or Unexpected Reset
 26
Loss Of Power
 22
Computer Software Problem
 22
Failure Of Device To Self-Test
 21
Suction Failure
 19
Unexpected Shutdown
 18
Defective Alarm
 18
Inaccurate Delivery
18
No Pressure
 17
Failure To Deliver
 16
Device Stops Intermittently
 15
Detachment Of Device Or Device Component
 15
Air Leak
 14
No Audible Alarm
 14
No Flow
 14
Electrical /Electronic Property Problem
 14
Incorrect, Inadequate Or Imprecise Result Or Readings
 13
Failure To Run On Battery
 11
Gas Output Problem
11
Failure To Calibrate
 11
Power Problem
 11
Data Problem
 11
Improper Flow Or Infusion
 10
Crack
 10
Failure To Power Up
 9
Partial Blockage
 9
Reset Problem
 9
Computer Operating System Problem
 8
Display Or Visual Feedback Problem
 8
Communication Or Transmission Problem
 8
Device Dislodged Or Dislocated
 8
Device Tipped Over
 7
Adverse Event Without Identified Device Or Use Problem
 7
Material Integrity Problem
 7
Operating System Becomes Nonfunctional
 6
Calibration Problem
 6
Device Damaged Prior To Use
6
Detachment Of Device Component
 6
Noise, Audible
 5
Inflation Problem
 5
Failure To Sense
5
Improper Device Output
 5
Defective Component
 5
Connection Problem
 5
Premature Discharge Of Battery
4
Circuit Failure
 4
Use Of Device Problem
 4
Decrease In Suction
 4
Disconnection
 4
Loose Or Intermittent Connection
 4
Alarm Not Visible
4
Component Falling
 3
Insufficient Flow Or Under Infusion
 3
Delivery System Failure
 3
Failure To Run On AC/DC
 3
Incorrect Or Inadequate Test Results
 3
No Device Output
3
Deflation Problem
 3
Valve
 3
Device Operational Issue
 3
Fire
 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally
 2
Misconnection
 2
Battery
 2
Device Sensing Problem
 2
Issue With Displayed Error Message
 2
Improper Or Incorrect Procedure Or Method
 2
Incorrect Measurement
 2
Deformation Due To Compressive Stress
2
Obstruction Of Flow
 2
Component Missing
2
Screen
 2
Application Program Freezes, Becomes Nonfunctional
2
Low Audible Alarm
 2
Insufficient Information
 2
Total Device Problems 7262
Recalls
Manufacturer Recall Class Date Posted
1
Beckman Coulter Inc.
 II Aug-30-2016
2
Del Mar Reynolds Medical, Ltd.
 II May-16-2017
3
Draeger Medical, Inc.
 II Jun-19-2018
4
Draeger Medical, Inc.
 I May-08-2018
5
Draeger Medical, Inc.
 I Dec-12-2015
6
Draeger Medical, Inc.
 II Jul-27-2015
7
GE Healthcare
 II Apr-02-2015
8
GE Healthcare, LLC
 II Nov-09-2018
9
GE Healthcare, LLC
 II Mar-26-2018
10
GE Healthcare, LLC
 II May-24-2017
11
GE Healthcare, LLC
 II Dec-14-2016
12
GE Medical Systems China Co., Ltd.
 II Aug-30-2018
13
GE Medical Systems China Co., Ltd.
 II Feb-09-2018
14
GE Medical Systems, LLC
 II Apr-22-2016
15
GE Medical Systems, LLC
 II Apr-13-2016
16
GE Medical Systems, LLC
 II Jan-21-2016
17
MCKESSON TECHNOLOGIES INC.
 I Mar-05-2014
18
Maquet Cardiovascular Us Sales, Llc
 I Feb-22-2016
19
Maquet Cardiovascular Us Sales, Llc
 II Jul-15-2015
20
Maquet Cardiovascular Us Sales, Llc
 I Jun-08-2015
21
Mindray DS USA, Inc. Dba Mindray North America
 II Mar-02-2018
22
Mindray DS USA, Inc. Dba Mindray North America
 II Aug-30-2016
23
Spacelabs Healthcare, Ltd.
 I Nov-21-2017
TPLC Last Update: 2019-04-02 19:26:45
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