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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 1426 1426

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 4909 5104
Mechanical Problem 3043 3071
Failure to Run on Battery 1863 1863
Device Operates Differently Than Expected 1482 1482
No Display/Image 1399 1399
Appropriate Term/Code Not Available 1063 1063
Output Problem 994 994
Gas/Air Leak 918 950
Failure to Deliver 792 792
Increase in Pressure 697 711
Device Alarm System 632 632
Unexpected Shutdown 626 631
Gas Output Problem 621 621
Insufficient Flow or Under Infusion 603 603
Device Displays Incorrect Message 587 587
Unexpected Therapeutic Results 567 570
Infusion or Flow Problem 533 543
Leak/Splash 469 469
Inaccurate Delivery 420 422
Break 394 398
Pressure Problem 384 388
Power Problem 331 331
Physical Resistance/Sticking 301 306
Suction Failure 291 295
Decrease in Suction 253 262
Electrical /Electronic Property Problem 252 252
Suction Problem 248 248
Device Inoperable 206 206
Inappropriate or Unexpected Reset 194 195
Failure to Power Up 173 173
No Visual Prompts/Feedback 168 168
Intermittent Continuity 160 160
Detachment of Device or Device Component 159 159
No Audible Alarm 150 151
Tidal Volume Fluctuations 148 148
Energy Output Problem 144 146
Excess Flow or Over-Infusion 128 128
Mechanical Jam 111 111
Insufficient Information 107 107
Intermittent Communication Failure 107 107
Decrease in Pressure 106 106
No Pressure 89 89
Loss of Power 82 82
Sticking 81 81
Battery Problem 77 77
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Protective Measures Problem 69 69
Complete Loss of Power 68 68
High Readings 66 66
Adverse Event Without Identified Device or Use Problem 65 65
No Flow 62 62
Display or Visual Feedback Problem 61 61
Failure of Device to Self-Test 57 57
Use of Device Problem 52 52
Defective Device 48 48
Failure to Analyze Signal 42 42
Improper Flow or Infusion 38 38
Computer Software Problem 36 36
Failure to Sense 35 35
Material Integrity Problem 34 34
Circuit Failure 33 33
Crack 32 32
Reset Problem 32 32
Defective Alarm 30 32
Calibration Problem 30 30
Failure to Calibrate 27 27
Loose or Intermittent Connection 26 26
Premature Discharge of Battery 23 23
Contamination /Decontamination Problem 22 22
Ventilation Problem in Device Environment 20 20
Computer Operating System Problem 18 18
Device Fell 18 18
Noise, Audible 18 18
Device Stops Intermittently 18 18
Disconnection 17 17
Device Sensing Problem 17 17
Air Leak 16 16
Device Tipped Over 16 16
Improper or Incorrect Procedure or Method 15 15
Data Problem 15 15
No Apparent Adverse Event 14 14
Activation Failure 14 14
Intermittent Loss of Power 12 12
Electrical Overstress 12 12
Defective Component 11 11
Component Missing 11 11
Communication or Transmission Problem 10 10
Computer System Security Problem 9 9
Device Damaged Prior to Use 9 9
Device Reprocessing Problem 9 9
Erratic or Intermittent Display 9 9
Fire 9 9
Inflation Problem 8 8
No Device Output 8 8
Degraded 8 8
Improper Device Output 8 8
Device Handling Problem 8 8
Connection Problem 7 7
Complete Blockage 7 7
Incorrect Measurement 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14394 14394
No Patient Involvement 7056 7092
No Consequences Or Impact To Patient 3183 3183
Insufficient Information 808 808
No Known Impact Or Consequence To Patient 525 800
Low Oxygen Saturation 114 114
Awareness during Anaesthesia 29 29
Cardiac Arrest 28 28
Death 27 27
No Information 27 27
Patient Problem/Medical Problem 16 16
No Code Available 13 13
Hypoxia 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Cyanosis 9 9
Low Blood Pressure/ Hypotension 7 7
Bradycardia 7 7
Loss of consciousness 6 6
Vomiting 5 5
Burn(s) 5 5
Pneumothorax 5 5
Brain Injury 5 5
Tachycardia 4 4
Therapeutic Effects, Unexpected 4 6
Hypoventilation 4 8
High Blood Pressure/ Hypertension 3 3
Cardiopulmonary Arrest 3 3
Apnea 3 3
Respiratory Distress 3 3
Oversedation 3 3
Coma 3 3
Unspecified Respiratory Problem 3 3
Partial thickness (Second Degree) Burn 2 2
Cough 2 2
Respiratory Arrest 2 2
Convulsion/Seizure 2 2
Injury 2 2
Respiratory Failure 2 2
Nausea 2 2
Urinary Retention 2 2
Blurred Vision 1 1
Cardiac Tamponade 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Arrhythmia 1 1
Abrasion 1 1
Airway Obstruction 1 1
Capsular Contracture 1 1
Dyspnea 1 1
Emotional Changes 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Headache 1 1
Suture Abrasion 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Sleep Dysfunction 1 1
Electric Shock 1 1
Lethargy 1 1
Loss Of Pulse 1 1
Bronchospasm 1 1
Overinflation of Lung 1 1
Reaction 1 1
Dizziness 1 1
Forced Expiratory Volume Decreased 1 1
Premature Labor 1 1
Respiratory Acidosis 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Blood or Lymphatic problem 1 1
Asystole 1 1
Intraoperative Pain 1 1
Test Result 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Urinary Incontinence 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. 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 Healthcare, LLC II Dec-14-2016
18 GE Medical Systems China Co., Ltd. II Aug-30-2018
19 GE Medical Systems China Co., Ltd. II Feb-09-2018
20 GE Medical Systems, LLC II Apr-22-2016
21 GE Medical Systems, LLC II Apr-13-2016
22 GE Medical Systems, LLC II Jan-21-2016
23 Getinge Group Logistics America, LLC II Mar-05-2021
24 Getinge Usa Sales Inc II Feb-06-2024
25 Getinge Usa Sales Inc I Jan-26-2023
26 Getinge Usa Sales Inc II Dec-07-2022
27 Getinge Usa Sales Inc I Jun-23-2022
28 Getinge Usa Sales Inc I Jan-10-2022
29 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
30 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
31 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
32 Spacelabs Healthcare, Ltd. I Nov-21-2017
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