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

MDR Year MDR Reports MDR Events
2019 1957 2270
2020 2687 2687
2021 3123 3123
2022 4350 4350
2023 5596 5596
2024 2905 2905

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 4983 5178
Mechanical Problem 2847 2875
Failure to Run on Battery 2100 2100
No Display/Image 1457 1457
Gas/Air Leak 900 932
Insufficient Flow or Under Infusion 812 812
Failure to Deliver 807 807
Increase in Pressure 683 697
Output Problem 683 683
Unexpected Shutdown 651 656
Gas Output Problem 642 642
Unexpected Therapeutic Results 599 602
Infusion or Flow Problem 504 514
Power Problem 427 427
Inaccurate Delivery 406 408
Electrical /Electronic Property Problem 283 283
Physical Resistance/Sticking 276 281
Suction Failure 273 277
Decrease in Suction 249 258
Break 214 218
Failure to Power Up 203 203
No Visual Prompts/Feedback 181 181
Inappropriate or Unexpected Reset 174 175
Pressure Problem 170 174
Intermittent Continuity 169 169
Detachment of Device or Device Component 145 145
No Audible Alarm 134 135
Insufficient Information 115 115
Decrease in Pressure 114 114
Intermittent Communication Failure 113 113
Complete Loss of Power 87 87
No Pressure 76 76
Protective Measures Problem 66 66
Leak/Splash 61 61
Adverse Event Without Identified Device or Use Problem 60 60
Battery Problem 57 57
Incorrect, Inadequate or Imprecise Result or Readings 54 54
Energy Output Problem 53 55
Use of Device Problem 50 50
Display or Visual Feedback Problem 50 50
No Flow 49 49
Device Displays Incorrect Message 47 47
Failure to Analyze Signal 44 44
Circuit Failure 31 31
Failure to Sense 31 31
Computer Software Problem 29 29
Defective Device 28 28
Appropriate Term/Code Not Available 28 28
Material Integrity Problem 27 27
Improper Flow or Infusion 25 25
Suction Problem 24 24
Contamination /Decontamination Problem 22 22
Premature Discharge of Battery 21 21
Crack 21 21
Calibration Problem 21 21
Loose or Intermittent Connection 21 21
Device Fell 19 19
Activation Failure 16 16
No Apparent Adverse Event 16 16
Defective Alarm 16 18
Reset Problem 16 16
Excess Flow or Over-Infusion 15 15
Intermittent Loss of Power 15 15
Disconnection 15 15
Tidal Volume Fluctuations 15 15
Complete Blockage 14 14
Device Alarm System 13 13
Device Sensing Problem 13 13
Electrical Overstress 12 12
Degraded 11 11
Device Tipped Over 10 10
Data Problem 10 10
Computer System Security Problem 9 9
Device Reprocessing Problem 9 9
Loss of Power 9 9
Device Handling Problem 9 9
Device-Device Incompatibility 8 8
Erratic or Intermittent Display 8 8
Improper or Incorrect Procedure or Method 8 8
Component Missing 8 8
Failure to Calibrate 7 7
No Device Output 7 7
Noise, Audible 7 7
Incorrect Interpretation of Signal 6 6
Failure to Reset 6 6
Fire 6 6
Human-Device Interface Problem 5 5
Defective Component 5 5
Inaccurate Flow Rate 5 5
Contamination 5 5
Chemical Problem 5 5
Decreased Pump Speed 5 5
Misassembly by Users 5 5
Loss of Threshold 5 5
Failure to Shut Off 5 5
Fluid/Blood Leak 4 4
Moisture or Humidity Problem 4 4
Image Display Error/Artifact 4 4
Device Difficult to Program or Calibrate 4 4
Ventilation Problem in Device Environment 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15871 15871
No Patient Involvement 2375 2411
No Consequences Or Impact To Patient 1170 1170
Insufficient Information 810 810
No Known Impact Or Consequence To Patient 205 480
Low Oxygen Saturation 95 95
Cardiac Arrest 24 24
Awareness during Anaesthesia 15 15
Death 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Information 7 7
Hypoxia 7 7
Cyanosis 7 7
Vomiting 6 6
Loss of consciousness 6 6
Bradycardia 5 5
Low Blood Pressure/ Hypotension 5 5
Tachycardia 4 4
Therapeutic Effects, Unexpected 3 5
Respiratory Distress 3 3
Oversedation 3 3
Pneumothorax 3 3
Brain Injury 3 3
Apnea 3 3
Cardiopulmonary Arrest 3 3
Respiratory Arrest 3 3
Unspecified Respiratory Problem 3 3
Patient Problem/Medical Problem 2 2
Cough 2 2
Convulsion/Seizure 2 2
Airway Obstruction 2 2
Burn(s) 2 2
Hypoventilation 2 6
Coma 2 2
Nausea 2 2
Cardiac Tamponade 1 1
Anxiety 1 1
Overinflation of Lung 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Urinary Retention 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Dyspnea 1 1
Emotional Changes 1 1
Eye Injury 1 1
Headache 1 1
High Blood Pressure/ Hypertension 1 1
Capsular Contracture 1 1
Arrhythmia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Blood or Lymphatic problem 1 1
Asystole 1 1
No Code Available 1 1
Respiratory Acidosis 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Electric Shock 1 1
Lethargy 1 1
Bronchospasm 1 1
Partial thickness (Second Degree) Burn 1 1
Intraoperative Pain 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. I Apr-18-2024
2 Draeger Medical, Inc. II Jan-14-2022
3 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
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 Getinge Group Logistics America, LLC II Mar-05-2021
12 Getinge Usa Sales Inc I May-31-2024
13 Getinge Usa Sales Inc II Feb-06-2024
14 Getinge Usa Sales Inc I Jan-26-2023
15 Getinge Usa Sales Inc II Dec-07-2022
16 Getinge Usa Sales Inc I Jun-23-2022
17 Getinge Usa Sales Inc I Jan-10-2022
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