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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
  1.  K191027  Flow-i Anesthesia System, Flow-c Anesthesia System ...
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 6071 6071
2025 435 435

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5592 5787
Mechanical Problem 3320 3348
Failure to Run on Battery 2614 2614
No Display/Image 1621 1621
Insufficient Flow or Under Infusion 1255 1255
Output Problem 1107 1107
Gas/Air Leak 1033 1065
Failure to Deliver 953 953
Unexpected Therapeutic Results 950 953
Increase in Pressure 767 781
Gas Output Problem 763 763
Unexpected Shutdown 759 764
Power Problem 747 747
Infusion or Flow Problem 569 579
Electrical /Electronic Property Problem 502 502
Inaccurate Delivery 443 445
Appropriate Term/Code Not Available 376 376
Physical Resistance/Sticking 310 315
Failure to Power Up 300 300
Break 291 295
Suction Failure 291 295
Pressure Problem 257 261
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 200 201
Leak/Splash 187 187
Intermittent Continuity 187 187
No Visual Prompts/Feedback 187 187
Detachment of Device or Device Component 164 164
Insufficient Information 149 149
Energy Output Problem 145 147
No Audible Alarm 140 141
Intermittent Communication Failure 132 132
Decrease in Pressure 129 129
No Pressure 113 113
Mechanical Jam 108 108
Complete Loss of Power 107 107
Suction Problem 103 103
Battery Problem 77 77
Adverse Event Without Identified Device or Use Problem 77 77
Protective Measures Problem 77 77
No Flow 77 77
No Apparent Adverse Event 75 75
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Excess Flow or Over-Infusion 63 63
Display or Visual Feedback Problem 61 61
Use of Device Problem 60 60
Tidal Volume Fluctuations 59 59

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19445 19445
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 115 115
Cardiac Arrest 29 29
Awareness during Anaesthesia 23 23
Death 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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
Bradycardia 6 6
Brain Injury 6 6
Low Blood Pressure/ Hypotension 5 5
No Code Available 5 5
Burn(s) 5 5
Oversedation 4 4
Capsular Contracture 4 4
Pneumothorax 4 4
Tachycardia 4 4
Apnea 3 3
Cardiopulmonary Arrest 3 3
Hypoventilation 3 7
Respiratory Distress 3 3
Nausea 3 3
Therapeutic Effects, Unexpected 3 5
Respiratory Arrest 3 3
Unspecified Respiratory Problem 3 3
Convulsion/Seizure 2 2
Headache 2 2
Urinary Retention 2 2
Partial thickness (Second Degree) Burn 2 2
Coma 2 2
Cough 2 2
Airway Obstruction 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Abrasion 1 1
Intraoperative Pain 1 1
Bone Fracture(s) 1 1
Sudden Cardiac Death 1 1
Dyspnea 1 1
Suture Abrasion 1 1
Pulmonary Insufficiency 1 1
Fecal Incontinence 1 1
Urinary Incontinence 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 May-31-2024
22 Getinge Usa Sales Inc II Feb-06-2024
23 Getinge Usa Sales Inc I Jan-26-2023
24 Getinge Usa Sales Inc II Dec-07-2022
25 Getinge Usa Sales Inc I Jun-23-2022
26 Getinge Usa Sales Inc I Jan-10-2022
27 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
28 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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