Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
CODONICS.INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
  1.  K191027  Flow-i Anesthesia System, Flow-c Anesthesia System ...
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 2589 2590
2019 1957 2270
2020 2687 2688
2021 3123 3124
2022 4352 4355
2023 5595 5596
2024 6067 6067
2025 9366 9366
2026 2922 2922

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6719 6914
Mechanical Problem 4341 4369
No Flow 3904 3904
Failure to Run on Battery 3707 3707
Insufficient Flow or Under Infusion 2351 2351
No Display/Image 1637 1637
Power Problem 1500 1500
Unexpected Therapeutic Results 1358 1361
Output Problem 1264 1264
Gas/Air Leak 1257 1290
Failure to Deliver 1252 1252
Electrical /Electronic Property Problem 1229 1229
Gas Output Problem 1044 1045
Increase in Pressure 937 951
Unexpected Shutdown 893 898
Infusion or Flow Problem 734 744
Inaccurate Delivery 484 486
Failure to Power Up 449 449
Appropriate Term/Code Not Available 378 378
Pressure Problem 362 366
Physical Resistance/Sticking 319 324
Leak/Splash 302 302
Suction Failure 291 295
Break 291 295
Decrease in Suction 251 260
Improper Flow or Infusion 234 234
Intermittent Continuity 226 226
Insufficient Information 219 219
Inappropriate or Unexpected Reset 219 220
Device Displays Incorrect Message 208 208
Device Alarm System 208 208
Device Operates Differently Than Expected 202 202
No Visual Prompts/Feedback 187 187
Decrease in Pressure 178 178
No Apparent Adverse Event 176 176
Detachment of Device or Device Component 171 171
Intermittent Communication Failure 166 166
No Pressure 155 155
Energy Output Problem 145 147
Complete Loss of Power 141 141
No Audible Alarm 140 141
Protective Measures Problem 113 113
Mechanical Jam 108 108
Suction Problem 103 103
Excess Flow or Over-Infusion 103 103
Adverse Event Without Identified Device or Use Problem 102 103
Battery Problem 101 101
Failure to Analyze Signal 98 98
Use of Device Problem 85 88
Degraded 83 83

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31159 31161
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1926
Insufficient Information 849 852
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 152 152
Cardiac Arrest 39 39
Hypoxia 32 32
Awareness during Anaesthesia 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Hypoventilation 23 27
Distress 20 20
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 14
Burn(s) 11 11
Cyanosis 9 9
Nausea 9 9
Vomiting 9 9
Loss of consciousness 9 9
Bradycardia 7 7
Pneumothorax 6 6
Brain Injury 6 6
Capsular Contracture 5 5
No Code Available 5 5
Low Blood Pressure/ Hypotension 5 5
Airway Obstruction 5 5
Tachycardia 4 4
Unspecified Respiratory Problem 4 4
Oversedation 4 4
Dizziness 4 4
Respiratory Arrest 4 4
Therapeutic Effects, Unexpected 3 5
Respiratory Distress 3 3
Emotional Changes 3 3
Cardiopulmonary Arrest 3 3
Apnea 3 3
Low Cardiac Output 2 2
Respiratory Insufficiency 2 2
Headache 2 2
Fecal Incontinence 2 2
Chills 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Convulsion/Seizure 2 2
Urinary Retention 2 2
Partial thickness (Second Degree) Burn 2 2
Laceration(s) 2 2
Coma 2 2
Asystole 2 2
Bronchospasm 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Datex-Ohmeda, Inc. I Oct-18-2024
2 Draeger Medical, Inc. I Dec-18-2024
3 Draeger Medical, Inc. I Nov-13-2024
4 Draeger Medical, Inc. I Apr-18-2024
5 Draeger Medical, Inc. II Jan-14-2022
6 Draeger Medical, Inc. II Jun-19-2018
7 Draeger Medical, Inc. I May-08-2018
8 Draeger, Inc. I Oct-01-2025
9 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
10 GE Healthcare, LLC II Jul-20-2022
11 GE Healthcare, LLC I Jul-19-2022
12 GE Healthcare, LLC II Jun-24-2022
13 GE Healthcare, LLC II Sep-30-2021
14 GE Healthcare, LLC II Oct-30-2020
15 GE Healthcare, LLC I Jan-23-2020
16 GE Healthcare, LLC II Dec-17-2019
17 GE Healthcare, LLC II Nov-09-2018
18 GE Healthcare, LLC II Mar-26-2018
19 GE Medical Systems China Co., Ltd. I Dec-18-2025
20 GE Medical Systems China Co., Ltd. I Apr-29-2025
21 GE Medical Systems China Co., Ltd. II Aug-30-2018
22 GE Medical Systems China Co., Ltd. II Feb-09-2018
23 Getinge Group Logistics America, LLC II Mar-05-2021
24 Getinge Usa Sales Inc I Feb-07-2025
25 Getinge Usa Sales Inc I May-31-2024
26 Getinge Usa Sales Inc II Feb-06-2024
27 Getinge Usa Sales Inc I Jan-26-2023
28 Getinge Usa Sales Inc II Dec-07-2022
29 Getinge Usa Sales Inc I Jun-23-2022
30 Getinge Usa Sales Inc I Jan-10-2022
31 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
32 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
33 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
-
-