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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
  1.  K213867  Carestation 750/750c
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

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 9366 9366
2026 1352 1352

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 6543 6738
Mechanical Problem 4249 4277
Failure to Run on Battery 3550 3550
No Flow 3449 3449
Insufficient Flow or Under Infusion 2168 2168
No Display/Image 1634 1634
Power Problem 1385 1385
Unexpected Therapeutic Results 1307 1310
Output Problem 1228 1228
Failure to Deliver 1224 1224
Gas/Air Leak 1222 1255
Electrical /Electronic Property Problem 1147 1147
Gas Output Problem 994 995
Increase in Pressure 905 919
Unexpected Shutdown 872 877
Infusion or Flow Problem 720 730
Inaccurate Delivery 477 479
Failure to Power Up 422 422
Appropriate Term/Code Not Available 378 378
Pressure Problem 355 359
Physical Resistance/Sticking 317 322
Suction Failure 291 295
Break 291 295
Leak/Splash 290 290
Decrease in Suction 251 260
Intermittent Continuity 224 224
Improper Flow or Infusion 220 220
Insufficient Information 211 211
Inappropriate or Unexpected Reset 210 211
Device Alarm System 208 208
Device Displays Incorrect Message 208 208
Device Operates Differently Than Expected 202 202
No Visual Prompts/Feedback 187 187
Decrease in Pressure 172 172
Detachment of Device or Device Component 170 170
No Apparent Adverse Event 169 169
Intermittent Communication Failure 160 160
No Pressure 151 151
Energy Output Problem 145 147
No Audible Alarm 140 141
Complete Loss of Power 140 140
Protective Measures Problem 110 110
Mechanical Jam 108 108
Suction Problem 103 103
Battery Problem 100 100
Excess Flow or Over-Infusion 98 98
Adverse Event Without Identified Device or Use Problem 98 99
Failure to Analyze Signal 95 95
Use of Device Problem 84 87
Degraded 78 78

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29622 29624
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1926
Insufficient Information 847 850
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 148 148
Cardiac Arrest 37 37
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
Burn(s) 10 10
Cyanosis 9 9
Vomiting 9 9
Loss of consciousness 9 9
Nausea 8 8
Bradycardia 7 7
Pneumothorax 6 6
Brain Injury 6 6
Airway Obstruction 5 5
Low Blood Pressure/ Hypotension 5 5
No Code Available 5 5
Capsular Contracture 5 5
Oversedation 4 4
Tachycardia 4 4
Unspecified Respiratory Problem 4 4
Respiratory Arrest 4 4
Dizziness 3 3
Therapeutic Effects, Unexpected 3 5
Cardiopulmonary Arrest 3 3
Respiratory Distress 3 3
Apnea 3 3
Hypoventilation 3 7
Partial thickness (Second Degree) Burn 2 2
Bronchospasm 2 2
Cough 2 2
Convulsion/Seizure 2 2
Asystole 2 2
Laceration(s) 2 2
Coma 2 2
Headache 2 2
Respiratory Insufficiency 2 2
Urinary Retention 2 2
Chills 2 2
Unspecified Mental, Emotional or Behavioural Problem 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 Dec-18-2025
20 GE Medical Systems China Co., Ltd. I Apr-29-2025
21 GE Medical Systems China Co., Ltd. II Aug-30-2018
22 GE Medical Systems China Co., Ltd. II Feb-09-2018
23 Getinge Group Logistics America, LLC II Mar-05-2021
24 Getinge Usa Sales Inc I Feb-07-2025
25 Getinge Usa Sales Inc I May-31-2024
26 Getinge Usa Sales Inc II Feb-06-2024
27 Getinge Usa Sales Inc I Jan-26-2023
28 Getinge Usa Sales Inc II Dec-07-2022
29 Getinge Usa Sales Inc I Jun-23-2022
30 Getinge Usa Sales Inc I Jan-10-2022
31 Mindray DS USA, Inc. dba Mindray North America II Nov-26-2025
32 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
33 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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