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

MDR Year MDR Reports MDR Events
2018 2588 2588
2019 1957 2270
2020 2687 2687
2021 3124 3124
2022 4323 4323

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 3925 4120
Mechanical Problem 1903 1931
Output Problem 748 748
Gas/Air Leak 725 757
No Display/Image 700 700
Failure to Run on Battery 610 610
Failure to Deliver 556 556
Increase in Pressure 530 544
Unexpected Shutdown 456 461
Gas Output Problem 434 434
Infusion or Flow Problem 427 437
Appropriate Term/Code Not Available 375 375
Unexpected Therapeutic Results 321 324
Inaccurate Delivery 317 319
Physical Resistance/Sticking 277 282
Break 262 266
Suction Failure 253 257
Decrease in Suction 237 246
Device Alarm System 204 204
Device Operates Differently Than Expected 202 202
Device Displays Incorrect Message 197 197
Pressure Problem 163 167
Inappropriate or Unexpected Reset 153 154
Detachment of Device or Device Component 139 139
Energy Output Problem 138 140
Leak/Splash 121 121
No Audible Alarm 117 118
Intermittent Continuity 111 111
Mechanical Jam 108 108
Suction Problem 86 86
No Pressure 83 83
Intermittent Communication Failure 77 77
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Decrease in Pressure 65 65
No Visual Prompts/Feedback 65 65
Protective Measures Problem 57 57
Tidal Volume Fluctuations 53 53
Insufficient Information 51 51
Defective Device 45 45
Battery Problem 45 45
Excess Flow or Over-Infusion 39 39
No Flow 39 39
High Readings 36 36
Display or Visual Feedback Problem 35 35
Adverse Event Without Identified Device or Use Problem 34 34
Material Integrity Problem 34 34
Computer Software Problem 31 31
Failure to Analyze Signal 31 31
Use of Device Problem 30 30
Crack 25 25
Sticking 23 23
Failure of Device to Self-Test 23 23
Improper Flow or Infusion 23 23
Circuit Failure 22 22
Loose or Intermittent Connection 22 22
Failure to Sense 21 21
Complete Loss of Power 20 20
Loss of Power 19 19
Defective Alarm 19 21
Device Fell 18 18
Contamination /Decontamination Problem 17 17
Device Tipped Over 14 14
Premature Discharge of Battery 13 13
Calibration Problem 12 12
Device Sensing Problem 12 12
Failure to Calibrate 11 11
Noise, Audible 11 11
Activation Failure 10 10
Reset Problem 10 10
Power Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Defective Component 10 10
Device Inoperable 10 10
Electrical /Electronic Property Problem 10 10
Disconnection 9 9
Insufficient Flow or Under Infusion 9 9
Computer System Security Problem 9 9
Ventilation Problem in Device Environment 9 9
No Apparent Adverse Event 8 8
Component Missing 8 8
Device Reprocessing Problem 8 8
Failure to Power Up 8 8
Electrical Overstress 7 7
Data Problem 7 7
Communication or Transmission Problem 6 6
Computer Operating System Problem 6 6
Loss of Threshold 6 6
No Device Output 6 6
Inflation Problem 5 5
Inaccurate Flow Rate 5 5
Fire 5 5
Device Handling Problem 5 5
Misassembly by Users 4 4
Free or Unrestricted Flow 4 4
Moisture or Humidity Problem 4 4
Material Split, Cut or Torn 4 4
Intermittent Loss of Power 4 4
Complete Blockage 4 4
False Alarm 4 4
Fluid/Blood Leak 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7412 7412
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1925
Insufficient Information 771 771
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 70 70
Cardiac Arrest 22 22
Awareness during Anaesthesia 18 18
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 13
Hypoxia 8 8
Cyanosis 7 7
No Code Available 5 5
Loss of consciousness 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Vomiting 4 4
Brain Injury 4 4
Tachycardia 4 4
Low Blood Pressure/ Hypotension 4 4
Burn(s) 4 4
Bradycardia 3 3
Cardiopulmonary Arrest 3 3
Hypoventilation 3 7
Therapeutic Effects, Unexpected 3 5
Pneumothorax 3 3
Respiratory Distress 3 3
Nausea 2 2
Oversedation 2 2
Urinary Retention 2 2
Partial thickness (Second Degree) Burn 2 2
Convulsion/Seizure 2 2
Respiratory Arrest 2 2
Metal Related Pathology 1 1
Solid Tumour 1 1
Urinary Incontinence 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Cough 1 1
Premature Labor 1 1
Intraoperative Pain 1 1
Respiratory Acidosis 1 1
Suture Abrasion 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Lethargy 1 1
Blurred Vision 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Cardiac Tamponade 1 1
Injury 1 1
Overinflation of Lung 1 1
Coma 1 1
Failure of Implant 1 1
Dyspnea 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Apnea 1 1
Arrhythmia 1 1
Abrasion 1 1
Airway Obstruction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. II Jan-14-2022
2 Draeger Medical, Inc. II Jun-19-2018
3 Draeger Medical, Inc. I May-08-2018
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 GE Healthcare, LLC II Nov-09-2018
12 GE Healthcare, LLC II Mar-26-2018
13 GE Medical Systems China Co., Ltd. II Aug-30-2018
14 GE Medical Systems China Co., Ltd. II Feb-09-2018
15 Getinge Group Logistics America, LLC II Mar-05-2021
16 Getinge Usa Sales Inc I Jan-26-2023
17 Getinge Usa Sales Inc II Dec-07-2022
18 Getinge Usa Sales Inc I Jun-23-2022
19 Getinge Usa Sales Inc I Jan-10-2022
20 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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