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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
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 4350 4350
2023 5596 5596
2024 4030 4030

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5236 5431
Mechanical Problem 3080 3108
Failure to Run on Battery 2233 2233
No Display/Image 1604 1604
Output Problem 1051 1051
Gas/Air Leak 985 1017
Insufficient Flow or Under Infusion 938 938
Failure to Deliver 854 854
Unexpected Therapeutic Results 748 751
Increase in Pressure 722 736
Unexpected Shutdown 686 691
Gas Output Problem 677 677
Infusion or Flow Problem 537 547
Power Problem 521 521
Inaccurate Delivery 429 431
Appropriate Term/Code Not Available 376 376
Electrical /Electronic Property Problem 357 357
Physical Resistance/Sticking 307 312
Suction Failure 291 295
Break 290 294
Decrease in Suction 250 259
Failure to Power Up 238 238
Pressure Problem 224 228
Device Displays Incorrect Message 208 208
Device Alarm System 205 205
Device Operates Differently Than Expected 202 202
Inappropriate or Unexpected Reset 192 193
No Visual Prompts/Feedback 187 187
Intermittent Continuity 175 175
Leak/Splash 160 160
Detachment of Device or Device Component 159 159
Energy Output Problem 144 146
No Audible Alarm 139 140
Insufficient Information 122 122
Decrease in Pressure 119 119
Intermittent Communication Failure 115 115
Mechanical Jam 108 108
Suction Problem 103 103
No Pressure 101 101
Complete Loss of Power 97 97
Adverse Event Without Identified Device or Use Problem 72 72
Battery Problem 71 71
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Protective Measures Problem 69 69
No Flow 65 65
Display or Visual Feedback Problem 58 58
Tidal Volume Fluctuations 56 56
Excess Flow or Over-Infusion 54 54
Use of Device Problem 53 53
Failure to Analyze Signal 48 48

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16991 16991
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1925
Insufficient Information 812 812
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 105 105
Cardiac Arrest 28 28
Awareness during Anaesthesia 22 22
Death 18 18
Patient Problem/Medical Problem 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
No Information 13 13
Cyanosis 9 9
Hypoxia 9 9
Vomiting 6 6
Loss of consciousness 6 6
Bradycardia 6 6
Low Blood Pressure/ Hypotension 5 5
Brain Injury 5 5
Burn(s) 5 5
No Code Available 5 5
Pneumothorax 4 4
Tachycardia 4 4
Hypoventilation 3 7
Oversedation 3 3
Nausea 3 3
Respiratory Distress 3 3
Apnea 3 3
Cardiopulmonary Arrest 3 3
Respiratory Arrest 3 3
Therapeutic Effects, Unexpected 3 5
Unspecified Respiratory Problem 3 3
Convulsion/Seizure 2 2
Capsular Contracture 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
Premature Labor 1 1
Bone Fracture(s) 1 1
Sudden Cardiac Death 1 1
Dyspnea 1 1
Unspecified Blood or Lymphatic problem 1 1
Pulmonary Edema 1 1
Low Cardiac Output 1 1
Urinary Incontinence 1 1
Anxiety 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I Apr-18-2024
2 Draeger Medical, Inc. II Jan-14-2022
3 Draeger Medical, Inc. II Jun-19-2018
4 Draeger Medical, Inc. I May-08-2018
5 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
6 GE Healthcare, LLC II Jul-20-2022
7 GE Healthcare, LLC I Jul-19-2022
8 GE Healthcare, LLC II Jun-24-2022
9 GE Healthcare, LLC II Sep-30-2021
10 GE Healthcare, LLC II Oct-30-2020
11 GE Healthcare, LLC I Jan-23-2020
12 GE Healthcare, LLC II Dec-17-2019
13 GE Healthcare, LLC II Nov-09-2018
14 GE Healthcare, LLC II Mar-26-2018
15 GE Medical Systems China Co., Ltd. II Aug-30-2018
16 GE Medical Systems China Co., Ltd. II Feb-09-2018
17 Getinge Group Logistics America, LLC II Mar-05-2021
18 Getinge Usa Sales Inc I May-31-2024
19 Getinge Usa Sales Inc II Feb-06-2024
20 Getinge Usa Sales Inc I Jan-26-2023
21 Getinge Usa Sales Inc II Dec-07-2022
22 Getinge Usa Sales Inc I Jun-23-2022
23 Getinge Usa Sales Inc I Jan-10-2022
24 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
25 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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