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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gas-machine, anesthesia
Regulation Description Gas machine for anesthesia or analgesia.
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 7
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
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  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 1398
No code available 1081
Device alarm system issue 582
Device displays error message 452
Leak 373
Pressure issue 243
Mechanical issue 224
Device inoperable 209
Suction issue 185
Tidal volume fluctuations 142
Break 121
Excess flow or overinfusion 105
No display or display failure 67
Sticking 62
High Readings 54
Infusion or flow issue 36
Battery issue 27
Increase in pressure 23
Loss of power 22
Defective Alarm 16
Computer software issue 16
Device stops intermittently 15
Air leak 14
Failure to deliver 12
Inappropriate or unexpected reset 11
Power source issue 11
Data Issue 11
Not audible alarm 10
Failure of device to self-test 10
Blockage within device or device component 9
Electrical issue 9
Dislodged or dislocated 8
Reset issue 8
Failure to power-up 8
Crack 8
Incorrect display 7
Improper flow or infusion 7
Failure to calibrate 7
No flow 7
Operating system becomes non-functional 6
Gas leak 6
Output issue 6
Device damaged prior to use 6
Computer operating system issue 6
Detachment of device component 6
Noise, Audible 5
Inaccurate delivery 5
Calibration issue 5
Inflation issue 5
Improper device output 5
Defective component 5
Connection issue 5
Tipover 4
Use of Device Issue 4
Improper gas output 4
Communication or transmission issue 4
Disconnection 4
Alarm not visible 4
Decrease in suction 3
Loose or intermittent connection 3
Insufficient flow or underinfusion 3
Component falling 3
Delivery system failure 3
Incorrect or inadequate test results 3
No device output 3
Failure to run on AC/DC 3
Deflation issue 3
Premature discharge of battery 3
No Known Device Problem 3
Incorrect measurement 2
Obstruction within device 2
Component missing 2
Fire 2
Application interface becomes non-functional or program exits abnormally 2
Misconnection 2
Issue with displayed error message 2
Improper or incorrect procedure or method 2
Low audible alarm 2
Detachment of device or device component 2
No Information 2
Moisture or humidity problem 2
Mechanical jam 2
False device output 2
Protective measure issue 1
Patient Data Issue 1
Material separation 1
Application program issue 1
No Pressure 1
Image display error 1
Decrease in pressure 1
Loss of threshold 1
Arcing 1
Electrical shorting 1
Difficult or delayed activation 1
Erratic display 1
Failure to convert to back-up 1
Burn of device or device component 1
Inadequate user interface 1
Low battery impedance 1
Naturally worn 1
Total Device Problems 5783

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 Del Mar Reynolds Medical, Ltd. I Nov-20-2013
4 Draeger Medical, Inc. II Jun-19-2018
5 Draeger Medical, Inc. I May-08-2018
6 Draeger Medical, Inc. I Dec-12-2015
7 Draeger Medical, Inc. II Jul-27-2015
8 Draeger Medical, Inc. I Oct-10-2013
9 GE Healthcare II Apr-02-2015
10 GE Healthcare, LLC II Mar-26-2018
11 GE Healthcare, LLC II May-24-2017
12 GE Healthcare, LLC II Dec-14-2016
13 GE Healthcare, LLC I Oct-15-2013
14 GE Healthcare, LLC I Oct-15-2013
15 GE Healthcare, LLC II Sep-06-2013
16 GE Healthcare, LLC II Jun-03-2013
17 GE Medical Systems China Co., Ltd. II Feb-09-2018
18 GE Medical Systems, LLC II Apr-22-2016
19 GE Medical Systems, LLC II Apr-13-2016
20 GE Medical Systems, LLC II Jan-21-2016
21 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
22 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
23 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
24 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
25 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
26 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
27 Spacelabs Healthcare, Ltd. I Nov-21-2017

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