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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
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 2590
2019 1957 2270
2020 2687 2688
2021 3123 3124
2022 4352 4355
2023 5595 5596
2024 6067 6067
2025 8566 8566

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6310 6505
Mechanical Problem 4025 4053
Failure to Run on Battery 3365 3365
No Flow 2926 2926
Insufficient Flow or Under Infusion 1927 1927
No Display/Image 1631 1631
Unexpected Therapeutic Results 1246 1249
Output Problem 1217 1217
Power Problem 1198 1198
Failure to Deliver 1178 1178
Gas/Air Leak 1175 1208
Gas Output Problem 958 959
Electrical /Electronic Property Problem 946 946
Increase in Pressure 869 883
Unexpected Shutdown 849 854
Infusion or Flow Problem 698 708
Inaccurate Delivery 469 471
Failure to Power Up 394 394
Appropriate Term/Code Not Available 378 378
Pressure Problem 335 339
Physical Resistance/Sticking 316 321
Suction Failure 291 295
Break 291 295
Leak/Splash 265 265
Decrease in Suction 251 260
Intermittent Continuity 220 220
Device Displays Incorrect Message 208 208
Device Alarm System 208 208
Inappropriate or Unexpected Reset 206 207
Device Operates Differently Than Expected 202 202
Insufficient Information 197 197
No Visual Prompts/Feedback 187 187
Detachment of Device or Device Component 170 170
Decrease in Pressure 162 162
Intermittent Communication Failure 153 153
No Apparent Adverse Event 151 151
Improper Flow or Infusion 151 151
Energy Output Problem 145 147
No Audible Alarm 140 141
No Pressure 137 137
Complete Loss of Power 131 131
Mechanical Jam 108 108
Protective Measures Problem 104 104
Suction Problem 103 103
Battery Problem 95 95
Failure to Analyze Signal 93 93
Excess Flow or Over-Infusion 92 92
Adverse Event Without Identified Device or Use Problem 91 92
Use of Device Problem 77 80
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 27484 27486
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1926
Insufficient Information 841 844
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 144 144
Cardiac Arrest 35 35
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 9 9
Vomiting 9 9
Nausea 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
Respiratory Arrest 4 4
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
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
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