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
  1.  K230931  Atlan
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 2687
2021 3123 3124
2022 4352 4355
2023 5595 5595
2024 6067 6067
2025 7908 7908

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6253 6448
Mechanical Problem 3955 3983
Failure to Run on Battery 3270 3270
No Flow 2812 2812
Insufficient Flow or Under Infusion 1834 1834
No Display/Image 1631 1631
Unexpected Therapeutic Results 1219 1222
Output Problem 1212 1212
Failure to Deliver 1160 1160
Gas/Air Leak 1157 1190
Power Problem 1150 1150
Gas Output Problem 947 947
Electrical /Electronic Property Problem 886 886
Increase in Pressure 863 877
Unexpected Shutdown 845 850
Infusion or Flow Problem 697 707
Inaccurate Delivery 467 469
Failure to Power Up 388 388
Appropriate Term/Code Not Available 378 378
Pressure Problem 332 336
Physical Resistance/Sticking 316 321
Suction Failure 291 295
Break 291 295
Leak/Splash 261 261
Decrease in Suction 250 259
Intermittent Continuity 219 219
Device Displays Incorrect Message 208 208
Device Alarm System 207 207
Inappropriate or Unexpected Reset 206 207
Device Operates Differently Than Expected 202 202
Insufficient Information 194 194
No Visual Prompts/Feedback 187 187
Detachment of Device or Device Component 169 169
Decrease in Pressure 160 160
Intermittent Communication Failure 152 152
No Apparent Adverse Event 146 146
Energy Output Problem 145 147
No Audible Alarm 140 141
Improper Flow or Infusion 137 137
No Pressure 133 133
Complete Loss of Power 130 130
Mechanical Jam 108 108
Suction Problem 103 103
Protective Measures Problem 101 101
Battery Problem 94 94
Failure to Analyze Signal 90 90
Adverse Event Without Identified Device or Use Problem 89 89
Excess Flow or Over-Infusion 88 88
Use of Device Problem 75 78
Incorrect, Inadequate or Imprecise Result or Readings 71 71

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26826 26827
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1925
Insufficient Information 839 842
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 143 143
Cardiac Arrest 34 34
Awareness during Anaesthesia 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 14
Hypoxia 11 11
Cyanosis 9 9
Loss of consciousness 8 8
Nausea 8 8
Vomiting 8 8
Bradycardia 7 7
Burn(s) 7 7
Pneumothorax 6 6
Brain Injury 6 6
Low Blood Pressure/ Hypotension 5 5
Airway Obstruction 5 5
No Code Available 5 5
Capsular Contracture 5 5
Unspecified Respiratory Problem 4 4
Tachycardia 4 4
Oversedation 4 4
Apnea 3 3
Hypoventilation 3 7
Therapeutic Effects, Unexpected 3 5
Respiratory Distress 3 3
Respiratory Arrest 3 3
Dizziness 3 3
Cardiopulmonary Arrest 3 3
Laceration(s) 2 2
Coma 2 2
Asystole 2 2
Bronchospasm 2 2
Cough 2 2
Partial thickness (Second Degree) Burn 2 2
Convulsion/Seizure 2 2
Headache 2 2
Respiratory Insufficiency 2 2
Urinary Retention 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Chills 2 2
Low Cardiac Output 2 2
Fecal Incontinence 2 2
Emotional Changes 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 Apr-29-2025
20 GE Medical Systems China Co., Ltd. II Aug-30-2018
21 GE Medical Systems China Co., Ltd. II Feb-09-2018
22 Getinge Group Logistics America, LLC II Mar-05-2021
23 Getinge Usa Sales Inc I Feb-07-2025
24 Getinge Usa Sales Inc I May-31-2024
25 Getinge Usa Sales Inc II Feb-06-2024
26 Getinge Usa Sales Inc I Jan-26-2023
27 Getinge Usa Sales Inc II Dec-07-2022
28 Getinge Usa Sales Inc I Jun-23-2022
29 Getinge Usa Sales Inc I Jan-10-2022
30 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
31 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
-
-