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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 1

MDR Year MDR Reports MDR Events
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 5580 5580
Mechanical Problem 3531 3531
Failure to Run on Battery 3254 3254
No Flow 2783 2783
Insufficient Flow or Under Infusion 1831 1831
No Display/Image 1589 1589
Power Problem 1145 1145
Unexpected Therapeutic Results 1096 1096
Failure to Deliver 1084 1084
Gas/Air Leak 950 951
Gas Output Problem 895 895
Electrical /Electronic Property Problem 878 878
Output Problem 840 840
Increase in Pressure 754 754
Unexpected Shutdown 751 751
Infusion or Flow Problem 535 535
Inaccurate Delivery 399 399
Failure to Power Up 384 384
Pressure Problem 245 245
Suction Failure 223 223
Physical Resistance/Sticking 215 215
Intermittent Continuity 213 213
Decrease in Suction 196 196
Insufficient Information 192 192
No Visual Prompts/Feedback 187 187
Inappropriate or Unexpected Reset 158 158
Leak/Splash 153 153
Decrease in Pressure 150 150
Intermittent Communication Failure 148 148
Break 147 147
No Apparent Adverse Event 146 146
Detachment of Device or Device Component 130 130
Improper Flow or Infusion 130 130
Complete Loss of Power 128 128
No Audible Alarm 126 126
Failure to Analyze Signal 87 87
Protective Measures Problem 80 80
Battery Problem 78 78
Adverse Event Without Identified Device or Use Problem 77 77
No Pressure 76 76
Use of Device Problem 70 73
Display or Visual Feedback Problem 56 56
Excess Flow or Over-Infusion 51 51
Degraded 51 51
Computer Software Problem 42 42
Circuit Failure 38 38
Failure to Sense 37 37
Device Displays Incorrect Message 35 35
Output below Specifications 34 34
Energy Output Problem 33 33

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26820 26821
No Patient Involvement 1166 1166
Insufficient Information 839 842
No Consequences Or Impact To Patient 632 632
Low Oxygen Saturation 122 122
No Known Impact Or Consequence To Patient 40 40
Cardiac Arrest 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Awareness during Anaesthesia 13 13
Nausea 8 8
Hypoxia 8 8
Vomiting 8 8
Loss of consciousness 7 7
Bradycardia 6 6
Cyanosis 5 5
Airway Obstruction 5 5
Capsular Contracture 5 5
Low Blood Pressure/ Hypotension 4 4
Pneumothorax 4 4
Unspecified Respiratory Problem 4 4
No Information 4 4
Oversedation 4 4
Apnea 3 3
Death 3 3
Brain Injury 3 3
Respiratory Arrest 3 3
Dizziness 3 3
Tachycardia 3 3
Burn(s) 3 3
Respiratory Insufficiency 2 2
Headache 2 2
Convulsion/Seizure 2 2
Cough 2 2
Bronchospasm 2 2
Asystole 2 2
Laceration(s) 2 2
Cardiopulmonary Arrest 2 2
Chills 2 2
Low Cardiac Output 2 2
Fecal Incontinence 2 2
Emotional Changes 2 2
Swelling 1 1
Concussion 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Pulmonary Insufficiency 1 1
Dyspnea 1 1
Overinflation of Lung 1 1
Coma 1 1
Unspecified Blood or Lymphatic problem 1 1
Respiratory Acidosis 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, Inc. I Oct-01-2025
7 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
8 GE Healthcare, LLC II Jul-20-2022
9 GE Healthcare, LLC I Jul-19-2022
10 GE Healthcare, LLC II Jun-24-2022
11 GE Healthcare, LLC II Sep-30-2021
12 GE Healthcare, LLC II Oct-30-2020
13 GE Healthcare, LLC I Jan-23-2020
14 GE Medical Systems China Co., Ltd. I Apr-29-2025
15 Getinge Group Logistics America, LLC II Mar-05-2021
16 Getinge Usa Sales Inc I Feb-07-2025
17 Getinge Usa Sales Inc I May-31-2024
18 Getinge Usa Sales Inc II Feb-06-2024
19 Getinge Usa Sales Inc I Jan-26-2023
20 Getinge Usa Sales Inc II Dec-07-2022
21 Getinge Usa Sales Inc I Jun-23-2022
22 Getinge Usa Sales Inc I Jan-10-2022
23 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
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