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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
  1.  K230931  Atlan
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 2589
2019 1957 2270
2020 2687 2687
2021 3123 3123
2022 4352 4352
2023 5596 5596
2024 6067 6067
2025 1394 1394

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5734 5929
Mechanical Problem 3444 3472
Failure to Run on Battery 2727 2727
No Display/Image 1624 1624
Insufficient Flow or Under Infusion 1372 1372
Output Problem 1126 1126
Gas/Air Leak 1069 1101
Unexpected Therapeutic Results 1015 1018
Failure to Deliver 987 987
Power Problem 820 820
Gas Output Problem 799 799
Increase in Pressure 786 800
Unexpected Shutdown 781 786
Infusion or Flow Problem 606 616
Electrical /Electronic Property Problem 564 564
Inaccurate Delivery 449 451
Appropriate Term/Code Not Available 376 376
Failure to Power Up 323 323
Physical Resistance/Sticking 310 315
Break 291 295
Suction Failure 291 295
Pressure Problem 267 271
Decrease in Suction 250 259
Device Displays Incorrect Message 208 208
Device Alarm System 205 205
Device Operates Differently Than Expected 202 202
Inappropriate or Unexpected Reset 202 203
Leak/Splash 196 196
Intermittent Continuity 194 194
No Visual Prompts/Feedback 187 187
Detachment of Device or Device Component 165 165
Insufficient Information 159 159
Energy Output Problem 145 147
Decrease in Pressure 141 141
No Audible Alarm 140 141
Intermittent Communication Failure 136 136
No Pressure 114 114
Complete Loss of Power 113 113
Mechanical Jam 108 108
Suction Problem 103 103
No Apparent Adverse Event 91 91
No Flow 85 85
Adverse Event Without Identified Device or Use Problem 80 80
Protective Measures Problem 79 79
Battery Problem 78 78
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Failure to Analyze Signal 66 66
Excess Flow or Over-Infusion 66 66
Use of Device Problem 63 63
Display or Visual Feedback Problem 61 61

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20385 20385
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1925
Insufficient Information 815 815
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 122 122
Cardiac Arrest 30 30
Awareness during Anaesthesia 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 13
Cyanosis 9 9
Hypoxia 9 9
Loss of consciousness 8 8
Vomiting 7 7
Burn(s) 7 7
Bradycardia 6 6
Brain Injury 6 6
Low Blood Pressure/ Hypotension 5 5
No Code Available 5 5
Capsular Contracture 4 4
Tachycardia 4 4
Oversedation 4 4
Unspecified Respiratory Problem 4 4
Nausea 4 4
Pneumothorax 4 4
Therapeutic Effects, Unexpected 3 5
Respiratory Arrest 3 3
Respiratory Distress 3 3
Cardiopulmonary Arrest 3 3
Hypoventilation 3 7
Apnea 3 3
Headache 2 2
Convulsion/Seizure 2 2
Partial thickness (Second Degree) Burn 2 2
Chills 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Cough 2 2
Urinary Retention 2 2
Airway Obstruction 2 2
Bronchospasm 2 2
Coma 2 2
Blurred Vision 1 1
Respiratory Distress Syndrome of Newborns 1 1
Respiratory Insufficiency 1 1
Sudden Cardiac Death 1 1
Anxiety 1 1
Pulmonary Edema 1 1
Premature Labor 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 Medical, Inc. II Jun-19-2018
7 Draeger Medical, Inc. I May-08-2018
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 Healthcare, LLC II Dec-17-2019
16 GE Healthcare, LLC II Nov-09-2018
17 GE Healthcare, LLC II Mar-26-2018
18 GE Medical Systems China Co., Ltd. II Aug-30-2018
19 GE Medical Systems China Co., Ltd. II Feb-09-2018
20 Getinge Group Logistics America, LLC II Mar-05-2021
21 Getinge Usa Sales Inc I Feb-07-2025
22 Getinge Usa Sales Inc I May-31-2024
23 Getinge Usa Sales Inc II Feb-06-2024
24 Getinge Usa Sales Inc I Jan-26-2023
25 Getinge Usa Sales Inc II Dec-07-2022
26 Getinge Usa Sales Inc I Jun-23-2022
27 Getinge Usa Sales Inc I Jan-10-2022
28 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
29 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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