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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
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 3123
2022 4352 4352
2023 5596 5596
2024 6071 6071
2025 435 435

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 4919 4919
Mechanical Problem 2896 2896
Failure to Run on Battery 2598 2598
No Display/Image 1579 1579
Insufficient Flow or Under Infusion 1252 1252
Failure to Deliver 877 877
Unexpected Therapeutic Results 827 827
Gas/Air Leak 826 826
Power Problem 742 742
Output Problem 735 735
Gas Output Problem 711 711
Unexpected Shutdown 665 665
Increase in Pressure 658 658
Electrical /Electronic Property Problem 494 494
Infusion or Flow Problem 407 407
Inaccurate Delivery 375 375
Failure to Power Up 296 296
Suction Failure 223 223
Physical Resistance/Sticking 209 209
Decrease in Suction 196 196
No Visual Prompts/Feedback 187 187
Intermittent Continuity 181 181
Pressure Problem 170 170
Inappropriate or Unexpected Reset 152 152
Insufficient Information 147 147
Break 147 147
Intermittent Communication Failure 128 128
No Audible Alarm 126 126
Detachment of Device or Device Component 125 125
Decrease in Pressure 119 119
Complete Loss of Power 105 105
Leak/Splash 79 79
No Apparent Adverse Event 75 75
Adverse Event Without Identified Device or Use Problem 65 65
Battery Problem 61 61
Protective Measures Problem 56 56
No Pressure 56 56
Use of Device Problem 55 55
Display or Visual Feedback Problem 55 55
Failure to Analyze Signal 54 54
No Flow 48 48
Device Displays Incorrect Message 35 35
Circuit Failure 34 34
Energy Output Problem 33 33
Failure to Sense 32 32
Degraded 31 31
Computer Software Problem 29 29
Excess Flow or Over-Infusion 26 26
Improper Flow or Infusion 26 26
Calibration Problem 25 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19439 19439
No Patient Involvement 1166 1166
Insufficient Information 815 815
No Consequences Or Impact To Patient 632 632
Low Oxygen Saturation 94 94
No Known Impact Or Consequence To Patient 40 40
Cardiac Arrest 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Awareness during Anaesthesia 12 12
Loss of consciousness 7 7
Vomiting 7 7
Hypoxia 6 6
Bradycardia 5 5
Cyanosis 5 5
Capsular Contracture 4 4
No Information 4 4
Low Blood Pressure/ Hypotension 4 4
Oversedation 4 4
Apnea 3 3
Unspecified Respiratory Problem 3 3
Death 3 3
Respiratory Arrest 3 3
Nausea 3 3
Brain Injury 3 3
Tachycardia 3 3
Cough 2 2
Convulsion/Seizure 2 2
Pneumothorax 2 2
Headache 2 2
Cardiopulmonary Arrest 2 2
Airway Obstruction 2 2
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Respiratory Distress Syndrome of Newborns 1 1
Chills 1 1
Dizziness 1 1
Pulmonary Insufficiency 1 1
Pulmonary Edema 1 1
Cardiac Tamponade 1 1
Anxiety 1 1
Overinflation of Lung 1 1
Coma 1 1
Laceration(s) 1 1
Respiratory Acidosis 1 1
Low Cardiac Output 1 1
Electric Shock 1 1
Lethargy 1 1
Bronchospasm 1 1
Failure of Implant 1 1
Patient Problem/Medical Problem 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 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
7 GE Healthcare, LLC II Jul-20-2022
8 GE Healthcare, LLC I Jul-19-2022
9 GE Healthcare, LLC II Jun-24-2022
10 GE Healthcare, LLC II Sep-30-2021
11 GE Healthcare, LLC II Oct-30-2020
12 GE Healthcare, LLC I Jan-23-2020
13 Getinge Group Logistics America, LLC II Mar-05-2021
14 Getinge Usa Sales Inc I Feb-07-2025
15 Getinge Usa Sales Inc I May-31-2024
16 Getinge Usa Sales Inc II Feb-06-2024
17 Getinge Usa Sales Inc I Jan-26-2023
18 Getinge Usa Sales Inc II Dec-07-2022
19 Getinge Usa Sales Inc I Jun-23-2022
20 Getinge Usa Sales Inc I Jan-10-2022
21 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
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