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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
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 5154 5349
Mechanical Problem 2953 2981
Failure to Run on Battery 2223 2223
No Display/Image 1587 1587
Insufficient Flow or Under Infusion 936 936
Gas/Air Leak 931 963
Failure to Deliver 839 839
Output Problem 718 718
Increase in Pressure 696 710
Unexpected Therapeutic Results 677 680
Gas Output Problem 669 669
Unexpected Shutdown 667 672
Power Problem 520 520
Infusion or Flow Problem 519 529
Inaccurate Delivery 413 415
Electrical /Electronic Property Problem 351 351
Physical Resistance/Sticking 280 285
Suction Failure 273 277
Decrease in Suction 249 258
Failure to Power Up 236 236
Break 214 218
No Visual Prompts/Feedback 187 187
Pressure Problem 178 182
Inappropriate or Unexpected Reset 176 177
Intermittent Continuity 174 174
Detachment of Device or Device Component 145 145
No Audible Alarm 134 135
Insufficient Information 122 122
Decrease in Pressure 118 118
Intermittent Communication Failure 115 115
Complete Loss of Power 95 95
No Pressure 85 85
Protective Measures Problem 68 68
Leak/Splash 67 67
Adverse Event Without Identified Device or Use Problem 62 62
Battery Problem 61 61
Incorrect, Inadequate or Imprecise Result or Readings 54 54
Display or Visual Feedback Problem 54 54
Use of Device Problem 53 53
Energy Output Problem 53 55
No Flow 52 52
Failure to Analyze Signal 48 48
Device Displays Incorrect Message 47 47
Failure to Sense 32 32
Circuit Failure 31 31
Computer Software Problem 30 30
Defective Device 28 28
Appropriate Term/Code Not Available 28 28
Material Integrity Problem 27 27
No Apparent Adverse Event 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16989 16989
No Patient Involvement 2375 2411
No Consequences Or Impact To Patient 1170 1170
Insufficient Information 812 812
No Known Impact Or Consequence To Patient 205 480
Low Oxygen Saturation 97 97
Cardiac Arrest 25 25
Awareness during Anaesthesia 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Death 14 14
Cyanosis 7 7
Hypoxia 7 7
No Information 7 7
Loss of consciousness 6 6
Vomiting 6 6
Low Blood Pressure/ Hypotension 5 5
Bradycardia 5 5
Tachycardia 4 4
Respiratory Arrest 3 3
Brain Injury 3 3
Respiratory Distress 3 3
Nausea 3 3
Apnea 3 3
Therapeutic Effects, Unexpected 3 5
Oversedation 3 3
Unspecified Respiratory Problem 3 3
Pneumothorax 3 3
Cardiopulmonary Arrest 3 3
Patient Problem/Medical Problem 2 2
Airway Obstruction 2 2
Burn(s) 2 2
Convulsion/Seizure 2 2
Hypoventilation 2 6
Coma 2 2
Cough 2 2
Capsular Contracture 2 2
Lethargy 1 1
Respiratory Distress Syndrome of Newborns 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Partial thickness (Second Degree) Burn 1 1
Bronchospasm 1 1
Sudden Cardiac Death 1 1
Anxiety 1 1
Pulmonary Edema 1 1
Asystole 1 1
Eye Injury 1 1
Overinflation of Lung 1 1
Laceration(s) 1 1
Dyspnea 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 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
4 GE Healthcare, LLC II Jul-20-2022
5 GE Healthcare, LLC I Jul-19-2022
6 GE Healthcare, LLC II Jun-24-2022
7 GE Healthcare, LLC II Sep-30-2021
8 GE Healthcare, LLC II Oct-30-2020
9 GE Healthcare, LLC I Jan-23-2020
10 GE Healthcare, LLC II Dec-17-2019
11 Getinge Group Logistics America, LLC II Mar-05-2021
12 Getinge Usa Sales Inc I May-31-2024
13 Getinge Usa Sales Inc II Feb-06-2024
14 Getinge Usa Sales Inc I Jan-26-2023
15 Getinge Usa Sales Inc II Dec-07-2022
16 Getinge Usa Sales Inc I Jun-23-2022
17 Getinge Usa Sales Inc I Jan-10-2022
18 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
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