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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 4
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
2016 2135 2135
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 5238 5433
Mechanical Problem 3288 3316
Failure to Run on Battery 2233 2233
No Display/Image 1652 1652
Device Operates Differently Than Expected 1482 1482
Appropriate Term/Code Not Available 1063 1063
Output Problem 1056 1056
Gas/Air Leak 993 1025
Insufficient Flow or Under Infusion 941 941
Failure to Deliver 859 859
Unexpected Therapeutic Results 748 751
Increase in Pressure 741 755
Unexpected Shutdown 686 691
Gas Output Problem 683 683
Device Alarm System 632 632
Device Displays Incorrect Message 587 587
Infusion or Flow Problem 573 583
Power Problem 529 529
Leak/Splash 483 483
Inaccurate Delivery 436 438
Pressure Problem 410 414
Break 394 398
Electrical /Electronic Property Problem 361 361
Physical Resistance/Sticking 307 312
Suction Failure 291 295
Decrease in Suction 253 262
Suction Problem 248 248
Failure to Power Up 247 247
Device Inoperable 206 206
Inappropriate or Unexpected Reset 201 202
No Visual Prompts/Feedback 187 187
Intermittent Continuity 175 175
Detachment of Device or Device Component 160 160
Tidal Volume Fluctuations 150 150
No Audible Alarm 150 151
Energy Output Problem 144 146
Excess Flow or Over-Infusion 136 136
Insufficient Information 123 123
Decrease in Pressure 121 121
Intermittent Communication Failure 115 115
Mechanical Jam 111 111
No Pressure 103 103
Complete Loss of Power 97 97
Battery Problem 84 84
Loss of Power 82 82
Sticking 81 81
Adverse Event Without Identified Device or Use Problem 75 75
Protective Measures Problem 71 71
No Flow 70 70
Incorrect, Inadequate or Imprecise Result or Readings 69 69

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16991 16991
No Patient Involvement 7056 7092
No Consequences Or Impact To Patient 3183 3183
Insufficient Information 812 812
No Known Impact Or Consequence To Patient 525 800
Low Oxygen Saturation 119 119
Cardiac Arrest 30 30
Awareness during Anaesthesia 29 29
Death 27 27
No Information 27 27
Patient Problem/Medical Problem 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
No Code Available 13 13
Hypoxia 12 12
Cyanosis 9 9
Bradycardia 7 7
Low Blood Pressure/ Hypotension 7 7
Loss of consciousness 6 6
Vomiting 6 6
Pneumothorax 5 5
Brain Injury 5 5
Burn(s) 5 5
Hypoventilation 4 8
Tachycardia 4 4
Therapeutic Effects, Unexpected 4 6
High Blood Pressure/ Hypertension 3 3
Apnea 3 3
Coma 3 3
Nausea 3 3
Respiratory Distress 3 3
Respiratory Arrest 3 3
Cardiopulmonary Arrest 3 3
Unspecified Respiratory Problem 3 3
Oversedation 3 3
Capsular Contracture 2 2
Cough 2 2
Urinary Retention 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Convulsion/Seizure 2 2
Airway Obstruction 2 2
Respiratory Failure 2 2
Forced Expiratory Volume Decreased 1 1
Anxiety 1 1
Pulmonary Edema 1 1
Sudden Cardiac Death 1 1
Bronchospasm 1 1
Blurred Vision 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-30-2016
2 Del Mar Reynolds Medical, Ltd. II May-16-2017
3 Draeger Medical, Inc. I Apr-18-2024
4 Draeger Medical, Inc. II Jan-14-2022
5 Draeger Medical, Inc. II Jun-19-2018
6 Draeger Medical, Inc. I May-08-2018
7 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
8 GE Healthcare, LLC II Jul-20-2022
9 GE Healthcare, LLC I Jul-19-2022
10 GE Healthcare, LLC II Jun-24-2022
11 GE Healthcare, LLC II Sep-30-2021
12 GE Healthcare, LLC II Oct-30-2020
13 GE Healthcare, LLC I Jan-23-2020
14 GE Healthcare, LLC II Dec-17-2019
15 GE Healthcare, LLC II Nov-09-2018
16 GE Healthcare, LLC II Mar-26-2018
17 GE Healthcare, LLC II May-24-2017
18 GE Healthcare, LLC II Dec-14-2016
19 GE Medical Systems China Co., Ltd. II Aug-30-2018
20 GE Medical Systems China Co., Ltd. II Feb-09-2018
21 GE Medical Systems, LLC II Apr-22-2016
22 GE Medical Systems, LLC II Apr-13-2016
23 GE Medical Systems, LLC II Jan-21-2016
24 Getinge Group Logistics America, LLC II Mar-05-2021
25 Getinge Usa Sales Inc I May-31-2024
26 Getinge Usa Sales Inc II Feb-06-2024
27 Getinge Usa Sales Inc I Jan-26-2023
28 Getinge Usa Sales Inc II Dec-07-2022
29 Getinge Usa Sales Inc I Jun-23-2022
30 Getinge Usa Sales Inc I Jan-10-2022
31 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
32 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2024
33 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
34 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
35 Spacelabs Healthcare, Ltd. I Nov-21-2017
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