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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
  1.  K251352  Codonics Safe Labeling System-Point of Care Statio ...
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 2687 2688
2021 3123 3124
2022 4352 4355
2023 5595 5596
2024 6067 6067
2025 9366 9366
2026 4217 4217

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6174 6174
No Flow 4123 4123
Mechanical Problem 4017 4017
Failure to Run on Battery 3852 3852
Insufficient Flow or Under Infusion 2437 2437
No Display/Image 1589 1589
Power Problem 1581 1581
Electrical /Electronic Property Problem 1334 1334
Unexpected Therapeutic Results 1274 1274
Failure to Deliver 1203 1203
Gas/Air Leak 1069 1069
Gas Output Problem 1025 1026
Output Problem 883 883
Increase in Pressure 863 863
Unexpected Shutdown 821 821
Infusion or Flow Problem 577 577
Failure to Power Up 480 480
Inaccurate Delivery 423 423
Pressure Problem 268 268
Improper Flow or Infusion 245 245
Intermittent Continuity 225 225
Suction Failure 222 222
Insufficient Device Problem Information 219 219
Physical Resistance/Sticking 216 216
Leak/Splash 205 205
Decrease in Suction 197 197
Decrease in Pressure 192 192
No Apparent Adverse Event 191 191
No Visual Prompts/Feedback 187 187
Intermittent Communication Failure 176 176
Inappropriate or Unexpected Reset 174 174
Complete Loss of Power 146 146
Break 146 146
Detachment of Device or Device Component 133 133
No Audible Alarm 125 125
No Pressure 98 98
Failure to Analyze Signal 96 96
Adverse Event Without Identified Device or Use Problem 89 90
Protective Measures Problem 89 89
Degraded 86 86
Battery Problem 84 84
Use of Device Problem 75 75
Excess Flow or Over-Infusion 69 69
Circuit Failure 64 64
Output below Specifications 58 58
Computer Software Problem 48 48
Failure of Device to Self-Test 45 45
Display or Visual Feedback Problem 43 43
Failure to Sense 41 41
Device Sensing Problem 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32437 32439
No Patient Involvement 1166 1166
Insufficient Information 851 854
No Consequences Or Impact To Patient 632 633
Low Oxygen Saturation 136 136
No Known Impact Or Consequence To Patient 40 40
Cardiac Arrest 33 33
Hypoxia 29 29
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 23 23
Hypoventilation 21 21
Distress 20 20
Awareness during Anaesthesia 13 13
Nausea 9 9
Vomiting 9 9
Loss of consciousness 8 8
Burn(s) 7 7
Bradycardia 6 6
Capsular Contracture 5 5
Airway Obstruction 5 5
Pneumothorax 5 5
Cyanosis 5 5
Respiratory Arrest 5 5
No Information 4 4
Unspecified Respiratory Problem 4 4
Oversedation 4 4
Low Blood Pressure/ Hypotension 4 4
Dizziness 4 4
Death 3 3
Apnea 3 3
Tachycardia 3 3
Brain Injury 3 3
Emotional Changes 3 3
Cardiopulmonary Arrest 2 2
Chills 2 2
Respiratory Insufficiency 2 2
Laceration(s) 2 2
Headache 2 2
Asystole 2 2
Low Cardiac Output 2 2
Fecal Incontinence 2 2
Bronchospasm 2 2
Convulsion/Seizure 2 2
Cough 2 2
Dyspnea 1 1
Arrhythmia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Respiratory Distress Syndrome of Newborns 1 1
Pulmonary Edema 1 1
Urinary Incontinence 1 1
Unspecified Blood or Lymphatic 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 Draeger, Inc. I Jun-04-2026
7 Draeger, Inc. I Oct-01-2025
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 Medical Systems China Co., Ltd. I Dec-18-2025
16 GE Medical Systems China Co., Ltd. I Apr-29-2025
17 Getinge Group Logistics America, LLC II Mar-05-2021
18 Getinge Usa Sales Inc I Feb-07-2025
19 Getinge Usa Sales Inc I May-31-2024
20 Getinge Usa Sales Inc II Feb-06-2024
21 Getinge Usa Sales Inc I Jan-26-2023
22 Getinge Usa Sales Inc II Dec-07-2022
23 Getinge Usa Sales Inc I Jun-23-2022
24 Getinge Usa Sales Inc I Jan-10-2022
25 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
26 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
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