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
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K171292  A7 Anesthesia System
  2.  K171311  A5 Anesthesia System
  3.  K201957  A8, A9 Anesthesia System

MDR Year MDR Reports MDR Events
2018 2589 2589
2019 1957 2270
2020 2687 2687
2021 3123 3123
2022 4352 4352
2023 5596 5596
2024 6067 6067
2025 846 846

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5652 5847
Mechanical Problem 3370 3398
Failure to Run on Battery 2662 2662
No Display/Image 1623 1623
Insufficient Flow or Under Infusion 1312 1312
Output Problem 1119 1119
Gas/Air Leak 1052 1084
Unexpected Therapeutic Results 978 981
Failure to Deliver 964 964
Gas Output Problem 782 782
Increase in Pressure 777 791
Power Problem 771 771
Unexpected Shutdown 766 771
Infusion or Flow Problem 586 596
Electrical /Electronic Property Problem 530 530
Inaccurate Delivery 446 448
Appropriate Term/Code Not Available 376 376
Failure to Power Up 311 311
Physical Resistance/Sticking 310 315
Break 291 295
Suction Failure 291 295
Pressure Problem 264 268
Decrease in Suction 250 259
Device Displays Incorrect Message 208 208
Device Alarm System 205 205
Device Operates Differently Than Expected 202 202
Inappropriate or Unexpected Reset 201 202
Leak/Splash 190 190
Intermittent Continuity 189 189
No Visual Prompts/Feedback 187 187
Detachment of Device or Device Component 164 164
Insufficient Information 153 153
Energy Output Problem 145 147
No Audible Alarm 140 141
Decrease in Pressure 137 137
Intermittent Communication Failure 134 134
No Pressure 113 113
Complete Loss of Power 111 111
Mechanical Jam 108 108
Suction Problem 103 103
No Flow 82 82
No Apparent Adverse Event 82 82
Adverse Event Without Identified Device or Use Problem 78 78
Protective Measures Problem 78 78
Battery Problem 77 77
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Excess Flow or Over-Infusion 64 64
Display or Visual Feedback Problem 61 61
Failure to Analyze Signal 60 60
Use of Device Problem 60 60

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19845 19845
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1925
Insufficient Information 815 815
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 120 120
Cardiac Arrest 29 29
Awareness during Anaesthesia 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 13
Cyanosis 9 9
Hypoxia 9 9
Loss of consciousness 8 8
Vomiting 7 7
Bradycardia 6 6
Brain Injury 6 6
Low Blood Pressure/ Hypotension 5 5
No Code Available 5 5
Burn(s) 5 5
Capsular Contracture 4 4
Tachycardia 4 4
Oversedation 4 4
Nausea 4 4
Pneumothorax 4 4
Unspecified Respiratory Problem 3 3
Therapeutic Effects, Unexpected 3 5
Respiratory Arrest 3 3
Respiratory Distress 3 3
Hypoventilation 3 7
Cardiopulmonary Arrest 3 3
Apnea 3 3
Headache 2 2
Convulsion/Seizure 2 2
Partial thickness (Second Degree) Burn 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Cough 2 2
Urinary Retention 2 2
Airway Obstruction 2 2
Coma 2 2
Blurred Vision 1 1
Respiratory Distress Syndrome of Newborns 1 1
Respiratory Insufficiency 1 1
Bronchospasm 1 1
Sudden Cardiac Death 1 1
Anxiety 1 1
Pulmonary Edema 1 1
Premature Labor 1 1
Asystole 1 1

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 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
9 GE Healthcare, LLC II Jul-20-2022
10 GE Healthcare, LLC I Jul-19-2022
11 GE Healthcare, LLC II Jun-24-2022
12 GE Healthcare, LLC II Sep-30-2021
13 GE Healthcare, LLC II Oct-30-2020
14 GE Healthcare, LLC I Jan-23-2020
15 GE Healthcare, LLC II Dec-17-2019
16 GE Healthcare, LLC II Nov-09-2018
17 GE Healthcare, LLC II Mar-26-2018
18 GE Medical Systems China Co., Ltd. II Aug-30-2018
19 GE Medical Systems China Co., Ltd. II Feb-09-2018
20 Getinge Group Logistics America, LLC II Mar-05-2021
21 Getinge Usa Sales Inc I Feb-07-2025
22 Getinge Usa Sales Inc I May-31-2024
23 Getinge Usa Sales Inc II Feb-06-2024
24 Getinge Usa Sales Inc I Jan-26-2023
25 Getinge Usa Sales Inc II Dec-07-2022
26 Getinge Usa Sales Inc I Jun-23-2022
27 Getinge Usa Sales Inc I Jan-10-2022
28 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
29 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
-
-