Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device gas-machine, anesthesia
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 2589 2589
2019 1957 2270
2020 2687 2687
2021 3123 3123
2022 4350 4350
2023 4486 4486

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 4606 4801
Mechanical Problem 2574 2602
Failure to Run on Battery 1468 1468
No Display/Image 1171 1171
Output Problem 912 912
Gas/Air Leak 845 877
Failure to Deliver 706 706
Increase in Pressure 627 641
Unexpected Shutdown 565 570
Gas Output Problem 538 538
Infusion or Flow Problem 468 478
Unexpected Therapeutic Results 422 425
Inaccurate Delivery 393 395
Appropriate Term/Code Not Available 376 376
Physical Resistance/Sticking 295 300
Suction Failure 291 295
Break 288 292
Insufficient Flow or Under Infusion 255 255
Decrease in Suction 250 259
Device Displays Incorrect Message 207 207
Device Alarm System 205 205
Device Operates Differently Than Expected 202 202
Pressure Problem 181 185
Inappropriate or Unexpected Reset 180 181
Electrical /Electronic Property Problem 160 160
Detachment of Device or Device Component 156 156
Power Problem 150 150
No Visual Prompts/Feedback 149 149
Energy Output Problem 141 143
No Audible Alarm 139 140
Intermittent Continuity 138 138
Leak/Splash 126 126
Mechanical Jam 108 108
Suction Problem 103 103
Intermittent Communication Failure 92 92
No Pressure 84 84
Decrease in Pressure 83 83
Failure to Power Up 76 76
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Insufficient Information 69 69
Protective Measures Problem 66 66
Battery Problem 55 55
Tidal Volume Fluctuations 53 53
No Flow 51 51
Adverse Event Without Identified Device or Use Problem 50 50
Defective Device 47 47
Complete Loss of Power 43 43
Excess Flow or Over-Infusion 41 41
Display or Visual Feedback Problem 41 41
Use of Device Problem 40 40
Failure to Analyze Signal 38 38
High Readings 36 36
Material Integrity Problem 34 34
Computer Software Problem 32 32
Circuit Failure 29 29
Failure to Sense 27 27
Crack 26 26
Improper Flow or Infusion 26 26
Failure of Device to Self-Test 24 24
Sticking 23 23
Calibration Problem 22 22
Loose or Intermittent Connection 22 22
Loss of Power 20 20
Defective Alarm 20 22
Contamination /Decontamination Problem 19 19
Device Fell 18 18
Premature Discharge of Battery 16 16
Device Sensing Problem 15 15
Disconnection 14 14
Device Tipped Over 14 14
Failure to Calibrate 12 12
Improper or Incorrect Procedure or Method 12 12
Reset Problem 12 12
Activation Failure 11 11
Noise, Audible 11 11
Electrical Overstress 11 11
Device Inoperable 10 10
Defective Component 10 10
No Apparent Adverse Event 10 10
Intermittent Loss of Power 10 10
Ventilation Problem in Device Environment 9 9
Component Missing 9 9
Computer System Security Problem 9 9
Device Reprocessing Problem 9 9
Complete Blockage 7 7
No Device Output 7 7
Fire 7 7
Data Problem 7 7
Device-Device Incompatibility 6 6
Computer Operating System Problem 6 6
Fluid/Blood Leak 6 6
Communication or Transmission Problem 6 6
Loss of Threshold 6 6
Failure to Reset 5 5
Chemical Problem 5 5
Inaccurate Flow Rate 5 5
Inflation Problem 5 5
Device Handling Problem 5 5
Misassembly by Users 5 5
Material Split, Cut or Torn 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11885 11885
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1925
Insufficient Information 795 795
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 90 90
Cardiac Arrest 24 24
Awareness during Anaesthesia 22 22
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 13
Hypoxia 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Cyanosis 7 7
Bradycardia 6 6
Loss of consciousness 6 6
No Code Available 5 5
Low Blood Pressure/ Hypotension 5 5
Burn(s) 4 4
Pneumothorax 4 4
Tachycardia 4 4
Brain Injury 4 4
Vomiting 4 4
Oversedation 3 3
Respiratory Distress 3 3
Therapeutic Effects, Unexpected 3 5
Cardiopulmonary Arrest 3 3
Apnea 3 3
Hypoventilation 3 7
Unspecified Respiratory Problem 3 3
Convulsion/Seizure 2 2
Cough 2 2
Respiratory Arrest 2 2
Coma 2 2
Partial thickness (Second Degree) Burn 2 2
Urinary Retention 2 2
Nausea 2 2
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Blurred Vision 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Cardiac Tamponade 1 1
Injury 1 1
Overinflation of Lung 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Dyspnea 1 1
Emotional Changes 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Arrhythmia 1 1
Abrasion 1 1
Airway Obstruction 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
Electric Shock 1 1
Lethargy 1 1
Bronchospasm 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Urinary Incontinence 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
-
-