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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 3
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 2355 2355
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 5237 5432
Mechanical Problem 3106 3134
Failure to Run on Battery 2233 2233
No Display/Image 1624 1624
Output Problem 1056 1056
Device Operates Differently Than Expected 1012 1012
Gas/Air Leak 991 1023
Insufficient Flow or Under Infusion 940 940
Failure to Deliver 857 857
Unexpected Therapeutic Results 748 751
Appropriate Term/Code Not Available 739 739
Increase in Pressure 728 742
Unexpected Shutdown 686 691
Gas Output Problem 680 680
Infusion or Flow Problem 547 557
Power Problem 524 524
Device Alarm System 451 451
Inaccurate Delivery 433 435
Device Displays Incorrect Message 380 380
Electrical /Electronic Property Problem 357 357
Leak/Splash 348 348
Break 331 335
Physical Resistance/Sticking 307 312
Suction Failure 291 295
Pressure Problem 287 291
Decrease in Suction 251 260
Failure to Power Up 242 242
Inappropriate or Unexpected Reset 194 195
Suction Problem 194 194
No Visual Prompts/Feedback 187 187
Intermittent Continuity 175 175
Detachment of Device or Device Component 159 159
No Audible Alarm 147 148
Energy Output Problem 144 146
Insufficient Information 123 123
Decrease in Pressure 120 120
Intermittent Communication Failure 115 115
Excess Flow or Over-Infusion 115 115
Mechanical Jam 108 108
No Pressure 102 102
Complete Loss of Power 97 97
Device Inoperable 94 94
Tidal Volume Fluctuations 89 89
Battery Problem 74 74
Adverse Event Without Identified Device or Use Problem 74 74
Protective Measures Problem 70 70
Incorrect, Inadequate or Imprecise Result or Readings 69 69
High Readings 66 66
No Flow 66 66
Display or Visual Feedback Problem 60 60

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16991 16991
No Patient Involvement 5624 5660
No Consequences Or Impact To Patient 2626 2626
Insufficient Information 812 812
No Known Impact Or Consequence To Patient 382 657
Low Oxygen Saturation 111 111
Cardiac Arrest 30 30
Awareness during Anaesthesia 25 25
No Information 24 24
Death 20 20
Patient Problem/Medical Problem 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Hypoxia 11 11
No Code Available 11 11
Cyanosis 9 9
Bradycardia 6 6
Vomiting 6 6
Loss of consciousness 6 6
Low Blood Pressure/ Hypotension 6 6
Brain Injury 5 5
Burn(s) 5 5
Pneumothorax 4 4
Tachycardia 4 4
Respiratory Arrest 3 3
Respiratory Distress 3 3
Nausea 3 3
Therapeutic Effects, Unexpected 3 5
Unspecified Respiratory Problem 3 3
Oversedation 3 3
Hypoventilation 3 7
Apnea 3 3
Cardiopulmonary Arrest 3 3
Convulsion/Seizure 2 2
Partial thickness (Second Degree) Burn 2 2
Airway Obstruction 2 2
Respiratory Failure 2 2
Injury 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Cough 2 2
Urinary Retention 2 2
Coma 2 2
Capsular Contracture 2 2
Headache 1 1
Respiratory Distress Syndrome of Newborns 1 1
Blurred Vision 1 1
Bronchospasm 1 1
Sudden Cardiac Death 1 1
Forced Expiratory Volume Decreased 1 1
Anxiety 1 1
Pulmonary Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Del Mar Reynolds Medical, Ltd. II May-16-2017
2 Draeger Medical, Inc. I Apr-18-2024
3 Draeger Medical, Inc. II Jan-14-2022
4 Draeger Medical, Inc. II Jun-19-2018
5 Draeger Medical, Inc. I May-08-2018
6 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
7 GE Healthcare, LLC II Jul-20-2022
8 GE Healthcare, LLC I Jul-19-2022
9 GE Healthcare, LLC II Jun-24-2022
10 GE Healthcare, LLC II Sep-30-2021
11 GE Healthcare, LLC II Oct-30-2020
12 GE Healthcare, LLC I Jan-23-2020
13 GE Healthcare, LLC II Dec-17-2019
14 GE Healthcare, LLC II Nov-09-2018
15 GE Healthcare, LLC II Mar-26-2018
16 GE Healthcare, LLC II May-24-2017
17 GE Medical Systems China Co., Ltd. II Aug-30-2018
18 GE Medical Systems China Co., Ltd. II Feb-09-2018
19 Getinge Group Logistics America, LLC II Mar-05-2021
20 Getinge Usa Sales Inc I May-31-2024
21 Getinge Usa Sales Inc II Feb-06-2024
22 Getinge Usa Sales Inc I Jan-26-2023
23 Getinge Usa Sales Inc II Dec-07-2022
24 Getinge Usa Sales Inc I Jun-23-2022
25 Getinge Usa Sales Inc I Jan-10-2022
26 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
27 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
28 Spacelabs Healthcare, Ltd. I Nov-21-2017
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