• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
Device gas-machine, anesthesia
Regulation Description Gas machine for anesthesia or analgesia.
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


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 1195
Device Alarm System 619
Mechanical Problem 541
Device Displays Incorrect Message 473
Therapeutic or Diagnostic Output Failure 422
Leak / Splash 398
Output Problem 355
Pressure Problem 302
Suction Problem 229
Break 217
Device Inoperable 209
Tidal Volume Fluctuations 162
Gas Leak 159
Infusion or Flow Problem 156
Excess Flow or Over-Infusion 118
Mechanical Jam 107
Unexpected Therapeutic Results 105
Energy Output Problem 103
Increase in Pressure 92
No Display / Image 89
Physical Resistance / Sticking 80
Unexpected Shutdown 68
Sticking 67
High Readings 58
Suction Failure 52
Inappropriate or Unexpected Reset 48
Decrease in Suction 47
Inaccurate Delivery 44
Incorrect, Inadequate or Imprecise Result or Readings 41
Battery Problem 33
Failure to Deliver 33
Detachment of Device or device Component 28
Computer Software Problem 27
No Pressure 23
Loss of Power 22
Defective Alarm 22
No Audible Alarm 21
Gas output problem 21
Failure of Device to Self-Test 21
No Flow 15
Device Stops Intermittently 15
Crack 15
Failure to Calibrate 15
Failure to Run on Battery 14
Electrical /Electronic Property Problem 14
Air Leak 14
Improper Flow or Infusion 13
Power Problem 12
Material Integrity Problem 11
Data Problem 11
Device Tipped Over 9
Failure to Power Up 9
Partial Blockage 9
Reset Problem 9
Device Dislodged or Dislocated 8
Communication or Transmission Problem 8
Computer Operating System Problem 8
Display or Visual Feedback Problem 8
Adverse Event Without Identified Device or Use Problem 8
Decrease in Pressure 7
Calibration Problem 7
Alarm Not Visible 6
Device Damaged Prior to Use 6
Operating System Becomes Nonfunctional 6
Detachment Of Device Component 6
Improper Device Output 5
Moisture or Humidity Problem 5
Inflation Problem 5
Use of Device Problem 5
Failure to Sense 5
Defective Component 5
Noise, Audible 5
Connection Problem 5
Circuit Failure 4
Loose or Intermittent Connection 4
Component Missing 4
Disconnection 4
No Device Output 4
Unauthorized Access to Computer System 4
Premature Discharge of Battery 4
Failure To Run On AC/DC 3
Component Falling 3
Deflation Problem 3
Incorrect Or Inadequate Test Results 3
Valve 3
Delivery System Failure 3
Device Operational Issue 3
Insufficient Flow or Under Infusion 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2
Improper or Incorrect Procedure or Method 2
False Alarm 2
Erratic or Intermittent Display 2
Fire 2
Issue With Displayed Error Message 2
Obstruction of Flow 2
Battery 2
Low Audible Alarm 2
Incorrect Measurement 2
Device Fell 2
Total Device Problems 8607

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

-
-