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
  1.  K213867  Carestation 750/750c
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
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 3636 3636

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6814 7009
Mechanical Problem 4400 4428
No Flow 4121 4121
Failure to Run on Battery 3779 3779
Insufficient Flow or Under Infusion 2402 2402
No Display/Image 1638 1638
Power Problem 1536 1536
Unexpected Therapeutic Results 1381 1384
Electrical /Electronic Property Problem 1289 1289
Gas/Air Leak 1272 1305
Output Problem 1269 1269
Failure to Deliver 1266 1266
Gas Output Problem 1058 1059
Increase in Pressure 949 963
Unexpected Shutdown 907 912
Infusion or Flow Problem 736 746
Inaccurate Delivery 487 489
Failure to Power Up 461 461
Appropriate Term/Code Not Available 378 378
Pressure Problem 366 370
Physical Resistance/Sticking 320 325
Leak/Splash 310 310
Break 291 295
Suction Failure 291 295
Decrease in Suction 251 260
Improper Flow or Infusion 244 244
Intermittent Continuity 228 228
Inappropriate or Unexpected Reset 222 223
Insufficient Information 221 221
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 186 186
No Apparent Adverse Event 178 178
Detachment of Device or Device Component 171 171
Intermittent Communication Failure 169 169
No Pressure 156 156
Energy Output Problem 145 147
Complete Loss of Power 143 143
No Audible Alarm 140 141
Protective Measures Problem 115 115
Mechanical Jam 108 108
Excess Flow or Over-Infusion 106 106
Suction Problem 104 104
Adverse Event Without Identified Device or Use Problem 103 104
Battery Problem 101 101
Failure to Analyze Signal 98 98
Use of Device Problem 85 88
Degraded 84 84

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31866 31868
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1926
Insufficient Information 850 853
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 156 156
Cardiac Arrest 40 40
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
Pneumothorax 7 7
Bradycardia 7 7
Brain Injury 6 6
Capsular Contracture 5 5
No Code Available 5 5
Respiratory Arrest 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
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
Headache 2 2
Respiratory Insufficiency 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 Jun-04-2026
9 Draeger, Inc. I Oct-01-2025
10 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
11 GE Healthcare, LLC II Jul-20-2022
12 GE Healthcare, LLC I Jul-19-2022
13 GE Healthcare, LLC II Jun-24-2022
14 GE Healthcare, LLC II Sep-30-2021
15 GE Healthcare, LLC II Oct-30-2020
16 GE Healthcare, LLC I Jan-23-2020
17 GE Healthcare, LLC II Dec-17-2019
18 GE Healthcare, LLC II Nov-09-2018
19 GE Healthcare, LLC II Mar-26-2018
20 GE Medical Systems China Co., Ltd. I Dec-18-2025
21 GE Medical Systems China Co., Ltd. I Apr-29-2025
22 GE Medical Systems China Co., Ltd. II Aug-30-2018
23 GE Medical Systems China Co., Ltd. II Feb-09-2018
24 Getinge Group Logistics America, LLC II Mar-05-2021
25 Getinge Usa Sales Inc I Feb-07-2025
26 Getinge Usa Sales Inc I May-31-2024
27 Getinge Usa Sales Inc II Feb-06-2024
28 Getinge Usa Sales Inc I Jan-26-2023
29 Getinge Usa Sales Inc II Dec-07-2022
30 Getinge Usa Sales Inc I Jun-23-2022
31 Getinge Usa Sales Inc I Jan-10-2022
32 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
33 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
34 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
-
-