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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
Regulation Description Gas machine for anesthesia or analgesia.
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 2588 2588
2019 1957 2270
2020 2686 2686
2021 1492 1492

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 2392 2587
Device Operates Differently Than Expected 1482 1482
Mechanical Problem 1093 1121
Appropriate Term/Code Not Available 1062 1062
Device Alarm System 630 630
Device Displays Incorrect Message 558 558
Output Problem 509 509
Gas Leak 488 520
Leak/Splash 439 439
Infusion or Flow Problem 359 369
Increase in Pressure 355 369
Break 344 348
Pressure Problem 317 321
Failure to Deliver 314 314
Unexpected Shutdown 244 249
Gas Output Problem 238 238
Unexpected Therapeutic Results 237 240
Suction Problem 227 227
Physical Resistance/Sticking 209 214
Device Inoperable 206 206
Inaccurate Delivery 196 198
Suction Failure 165 169
Decrease in Suction 156 165
Tidal Volume Fluctuations 144 144
Energy Output Problem 132 134
Excess Flow or Over-Infusion 119 119
Mechanical Jam 110 110
No Display/Image 109 109
Inappropriate or Unexpected Reset 100 101
Detachment of Device or Device Component 87 87
Sticking 81 81
No Pressure 80 80
Loss of Power 78 78
Incorrect, Inadequate or Imprecise Resultor Readings 67 67
High Readings 66 66
Intermittent Continuity 63 63
No Audible Alarm 63 64
Failure of Device to Self-Test 55 55
Decrease in Pressure 43 43
No Flow 43 43
Protective Measures Problem 41 41
Defective Device 39 39
Battery Problem 37 37
Intermittent Communication Failure 37 37
Material Integrity Problem 29 29
Crack 28 28
Improper Flow or Infusion 26 26
Failure to Run on Battery 26 26
Failure to Calibrate 25 25
Insufficient Information 24 24
Loose or Intermittent Connection 24 24
Defective Alarm 23 25
Computer Software Problem 22 22
Reset Problem 21 21
Adverse Event Without Identified Device or Use Problem 19 19
Ventilation Problem in Device Environment 18 18
Device Stops Intermittently 18 18
Computer Operating System Problem 18 18
Display or Visual Feedback Problem 18 18
Air Leak 16 16
Noise, Audible 15 15
Failure to Analyze Signal 15 15
Device Fell 15 15
Power Problem 14 14
Device Tipped Over 14 14
Use of Device Problem 14 14
Failure to Sense 13 13
Failure to Power Up 13 13
Electrical /Electronic Property Problem 13 13
Circuit Failure 12 12
Data Problem 12 12
Improper or Incorrect Procedure or Method 11 11
Defective Component 11 11
Calibration Problem 11 11
Communication or Transmission Problem 10 10
Component Missing 10 10
Device Sensing Problem 9 9
Insufficient Flow or Under Infusion 8 8
Improper Device Output 8 8
Computer System Security Problem 8 8
Inflation Problem 7 7
Device Dislodged or Dislocated 6 6
Complete Loss of Power 6 6
Device Damaged Prior to Use 6 6
Self-Activation or Keying 6 6
Detachment Of Device Component 6 6
Inaccurate Flow Rate 6 6
Alarm Not Visible 6 6
Unable to Obtain Readings 6 6
Premature Discharge of Battery 5 5
Partial Blockage 5 5
Disconnection 5 5
Loss of Threshold 5 5
Connection Problem 5 5
Incorrect Measurement 5 5
Difficult to Open or Close 5 5
Device Handling Problem 4 4
Fire 4 4
Fluid Leak 4 4
No Device Output 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 7056 7092
No Consequences Or Impact To Patient 3182 3182
No Clinical Signs, Symptoms or Conditions 1889 1889
No Known Impact Or Consequence To Patient 525 800
Insufficient Information 406 406
Low Oxygen Saturation 55 55
No Information 27 27
Death 27 27
Awareness during Anaesthesia 24 24
Patient Problem/Medical Problem 16 16
Cardiac Arrest 14 14
No Code Available 13 13
Hypoxia 9 9
Cyanosis 6 6
Burn(s) 4 4
Hypoventilation 4 8
Therapeutic Effects, Unexpected 4 6
Pneumothorax 4 4
Respiratory Distress 3 3
Brain Injury 3 3
Low Blood Pressure/ Hypotension 3 3
Cardiopulmonary Arrest 3 3
High Blood Pressure/ Hypertension 2 2
Oversedation 2 2
Respiratory Failure 2 2
Coma 2 2
Partial thickness (Second Degree) Burn 2 2
Urinary Retention 2 2
Injury 2 2
Bradycardia 2 2
Apnea 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Reaction 1 1
Forced Expiratory Volume Decreased 1 1
Premature Labor 1 1
Suture Abrasion 1 1
Loss Of Pulse 1 1
Blurred Vision 1 1
Dizziness 1 1
Respiratory Distress Syndrome of Newborns 1 1
Tachycardia 1 1
Complaint, Ill-Defined 1 1
Intraoperative Pain 1 1
Respiratory Arrest 1 1
Test Result 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Metal Related Pathology 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Loss of consciousness 1 1
Cardiac Tamponade 1 1
Sudden Cardiac Death 1 1
Sleep Dysfunction 1 1
Swelling 1 1
Abrasion 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 Jun-19-2018
4 Draeger Medical, Inc. I May-08-2018
5 GE Healthcare, LLC II Oct-30-2020
6 GE Healthcare, LLC I Jan-23-2020
7 GE Healthcare, LLC II Dec-17-2019
8 GE Healthcare, LLC II Nov-09-2018
9 GE Healthcare, LLC II Mar-26-2018
10 GE Healthcare, LLC II May-24-2017
11 GE Healthcare, LLC II Dec-14-2016
12 GE Medical Systems China Co., Ltd. II Aug-30-2018
13 GE Medical Systems China Co., Ltd. II Feb-09-2018
14 GE Medical Systems, LLC II Apr-22-2016
15 GE Medical Systems, LLC II Apr-13-2016
16 GE Medical Systems, LLC II Jan-21-2016
17 Getinge Group Logistics America, LLC II Mar-05-2021
18 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
19 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
20 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
21 Spacelabs Healthcare, Ltd. I Nov-21-2017
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