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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
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
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 2589
2019 1957 2270
2020 2687 2687
2021 3123 3123
2022 4352 4352
2023 5596 5596
2024 6071 6071

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5534 5729
Mechanical Problem 3274 3302
Failure to Run on Battery 2568 2568
No Display/Image 1620 1620
Insufficient Flow or Under Infusion 1191 1191
Output Problem 1099 1099
Gas/Air Leak 1025 1057
Failure to Deliver 935 935
Unexpected Therapeutic Results 916 919
Increase in Pressure 760 774
Gas Output Problem 751 751
Unexpected Shutdown 744 749
Power Problem 705 705
Infusion or Flow Problem 556 566
Electrical /Electronic Property Problem 467 467
Inaccurate Delivery 441 443
Appropriate Term/Code Not Available 376 376
Physical Resistance/Sticking 309 314
Suction Failure 291 295
Break 291 295
Failure to Power Up 289 289
Pressure Problem 255 259
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
Intermittent Continuity 187 187
No Visual Prompts/Feedback 187 187
Leak/Splash 182 182
Detachment of Device or Device Component 163 163
Energy Output Problem 145 147
Insufficient Information 140 140
No Audible Alarm 140 141
Intermittent Communication Failure 129 129
Decrease in Pressure 126 126
Mechanical Jam 108 108
No Pressure 108 108
Complete Loss of Power 107 107
Suction Problem 103 103
Battery Problem 77 77
Protective Measures Problem 76 76
Adverse Event Without Identified Device or Use Problem 75 75
No Flow 74 74
Incorrect, Inadequate or Imprecise Result or Readings 69 69
No Apparent Adverse Event 62 62
Display or Visual Feedback Problem 61 61
Excess Flow or Over-Infusion 60 60
Use of Device Problem 59 59
Tidal Volume Fluctuations 59 59

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19015 19015
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 112 112
Cardiac Arrest 29 29
Awareness during Anaesthesia 23 23
Death 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Patient Problem/Medical Problem 15 15
No Information 13 13
Cyanosis 9 9
Hypoxia 9 9
Loss of consciousness 8 8
Vomiting 7 7
Brain Injury 6 6
Bradycardia 6 6
Low Blood Pressure/ Hypotension 5 5
No Code Available 5 5
Burn(s) 5 5
Pneumothorax 4 4
Tachycardia 4 4
Oversedation 4 4
Therapeutic Effects, Unexpected 3 5
Unspecified Respiratory Problem 3 3
Capsular Contracture 3 3
Cardiopulmonary Arrest 3 3
Hypoventilation 3 7
Apnea 3 3
Respiratory Distress 3 3
Nausea 3 3
Respiratory Arrest 3 3
Airway Obstruction 2 2
Headache 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Convulsion/Seizure 2 2
Urinary Retention 2 2
Partial thickness (Second Degree) Burn 2 2
Coma 2 2
Cough 2 2
Lethargy 1 1
High Blood Pressure/ Hypertension 1 1
Premature Labor 1 1
Respiratory Distress Syndrome of Newborns 1 1
Intraoperative Pain 1 1
Solid Tumour 1 1
Arrhythmia 1 1
Electric Shock 1 1
Blurred Vision 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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