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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 2
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 2588 2588
2019 1957 2270
2020 2687 2687
2021 3124 3124
2022 2280 2280

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 3493 3688
Mechanical Problem 1605 1633
Device Operates Differently Than Expected 1012 1012
Appropriate Term/Code Not Available 738 738
Output Problem 690 690
Gas Leak 671 703
Failure to Deliver 493 493
Increase in Pressure 482 496
Device Alarm System 450 450
No Display/Image 424 424
Infusion or Flow Problem 410 420
Gas Output Problem 393 393
Unexpected Shutdown 388 393
Device Displays Incorrect Message 359 359
Leak/Splash 308 308
Unexpected Therapeutic Results 300 303
Break 298 302
Inaccurate Delivery 280 282
Physical Resistance/Sticking 260 265
Suction Failure 231 235
Decrease in Suction 219 228
Pressure Problem 216 220
Failure to Run on Battery 206 206
Suction Problem 176 176
Energy Output Problem 136 138
Inappropriate or Unexpected Reset 130 131
Detachment of Device or Device Component 126 126
No Audible Alarm 108 109
Mechanical Jam 108 108
Intermittent Continuity 102 102
Excess Flow or Over-Infusion 100 100
Device Inoperable 94 94
Tidal Volume Fluctuations 85 85
No Pressure 82 82
Intermittent Communication Failure 68 68
Incorrect, Inadequate or Imprecise Resultor Readings 68 68
High Readings 66 66
Sticking 58 58
Decrease in Pressure 57 57
Loss of Power 56 56
Protective Measures Problem 55 55
Battery Problem 48 48
Defective Device 45 45
Insufficient Information 44 44
Failure of Device to Self-Test 41 41
No Flow 39 39
No Visual Prompts/Feedback 38 38
Material Integrity Problem 34 34
Computer Software Problem 32 32
Display or Visual Feedback Problem 30 30
Improper Flow or Infusion 28 28
Adverse Event Without Identified Device or Use Problem 27 27
Crack 27 27
Use of Device Problem 27 27
Failure to Analyze Signal 26 26
Defective Alarm 25 27
Failure to Calibrate 25 25
Loose or Intermittent Connection 23 23
Circuit Failure 20 20
Failure to Sense 19 19
Device Fell 18 18
Ventilation Problem in Device Environment 15 15
Contamination /Decontamination Problem 15 15
Device Tipped Over 14 14
Complete Loss of Power 14 14
Noise, Audible 14 14
Reset Problem 13 13
Power Problem 12 12
Calibration Problem 12 12
Improper or Incorrect Procedure or Method 12 12
Premature Discharge of Battery 12 12
Failure to Power Up 11 11
Insufficient Flow or Under Infusion 11 11
Computer Operating System Problem 11 11
Defective Component 10 10
Component Missing 10 10
Disconnection 10 10
Device Sensing Problem 10 10
Activation Failure 9 9
Electrical /Electronic Property Problem 9 9
Computer System Security Problem 9 9
Communication or Transmission Problem 8 8
Device Reprocessing Problem 7 7
Data Problem 7 7
Inaccurate Flow Rate 6 6
Device Dislodged or Dislocated 6 6
Electrical Overstress 6 6
Loss of Threshold 6 6
Unable to Obtain Readings 5 5
Inflation Problem 5 5
No Device Output 5 5
Fire 5 5
Device Handling Problem 5 5
No Apparent Adverse Event 5 5
Difficult to Open or Close 4 4
Human-Device Interface Problem 4 4
Moisture or Humidity Problem 4 4
Intermittent Loss of Power 4 4
Complete Blockage 4 4
Partial Blockage 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 5624 5660
No Clinical Signs, Symptoms or Conditions 5433 5433
No Consequences Or Impact To Patient 2626 2626
Insufficient Information 720 720
No Known Impact Or Consequence To Patient 382 657
Low Oxygen Saturation 68 68
No Information 24 24
Awareness during Anaesthesia 21 21
Cardiac Arrest 21 21
Death 20 20
Patient Problem/Medical Problem 15 15
No Code Available 11 11
Hypoxia 9 9
Cyanosis 7 7
Tachycardia 4 4
Brain Injury 4 4
Low Blood Pressure/ Hypotension 4 4
Burn(s) 4 4
Cardiopulmonary Arrest 3 3
Hypoventilation 3 7
Respiratory Distress 3 3
Vomiting 3 3
Therapeutic Effects, Unexpected 3 5
Pneumothorax 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Loss of consciousness 3 3
Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Respiratory Failure 2 2
Respiratory Arrest 2 2
Oversedation 2 2
Urinary Retention 2 2
Bradycardia 2 2
Apnea 1 1
Arrhythmia 1 1
Abrasion 1 1
Airway Obstruction 1 1
Nausea 1 1
Dyspnea 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Blurred Vision 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Dizziness 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Cardiac Tamponade 1 1
Complaint, Ill-Defined 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Convulsion/Seizure 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Cough 1 1
Suture Abrasion 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Sleep Dysfunction 1 1
Lethargy 1 1
Loss Of Pulse 1 1
Test Result 1 1
Intraoperative Pain 1 1
Coma 1 1
Forced Expiratory Volume Decreased 1 1
Premature Labor 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Del Mar Reynolds Medical, Ltd. II May-16-2017
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 GE Healthcare, LLC II Jul-20-2022
6 GE Healthcare, LLC I Jul-19-2022
7 GE Healthcare, LLC II Jun-24-2022
8 GE Healthcare, LLC II Sep-30-2021
9 GE Healthcare, LLC II Oct-30-2020
10 GE Healthcare, LLC I Jan-23-2020
11 GE Healthcare, LLC II Dec-17-2019
12 GE Healthcare, LLC II Nov-09-2018
13 GE Healthcare, LLC II Mar-26-2018
14 GE Healthcare, LLC II May-24-2017
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 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
21 Spacelabs Healthcare, Ltd. I Nov-21-2017
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