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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 479 479

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 4705 4900
Mechanical Problem 2612 2640
Failure to Run on Battery 1682 1682
No Display/Image 1269 1269
Gas/Air Leak 836 868
Failure to Deliver 743 743
Increase in Pressure 635 649
Output Problem 634 634
Unexpected Shutdown 587 592
Gas Output Problem 584 584
Insufficient Flow or Under Infusion 473 473
Infusion or Flow Problem 469 479
Unexpected Therapeutic Results 428 431
Inaccurate Delivery 389 391
Physical Resistance/Sticking 273 278
Suction Failure 273 277
Power Problem 263 263
Decrease in Suction 249 258
Break 213 217
Electrical /Electronic Property Problem 205 205
Inappropriate or Unexpected Reset 166 167
No Visual Prompts/Feedback 163 163
Pressure Problem 151 155
Intermittent Continuity 151 151
Detachment of Device or Device Component 143 143
No Audible Alarm 134 135
Failure to Power Up 132 132
Intermittent Communication Failure 105 105
Insufficient Information 100 100
Decrease in Pressure 100 100
No Pressure 69 69
Protective Measures Problem 65 65
Incorrect, Inadequate or Imprecise Result or Readings 54 54
Energy Output Problem 53 55
Battery Problem 53 53
Complete Loss of Power 53 53
Adverse Event Without Identified Device or Use Problem 47 47
Display or Visual Feedback Problem 47 47
Device Displays Incorrect Message 46 46
Use of Device Problem 45 45
Leak/Splash 44 44
No Flow 43 43
Failure to Analyze Signal 41 41
Failure to Sense 29 29
Defective Device 28 28
Circuit Failure 28 28
Appropriate Term/Code Not Available 28 28
Computer Software Problem 27 27
Material Integrity Problem 27 27
Improper Flow or Infusion 24 24
Suction Problem 24 24
Contamination /Decontamination Problem 22 22
Crack 21 21
Loose or Intermittent Connection 21 21
Calibration Problem 20 20
Device Fell 18 18
Defective Alarm 16 18
Premature Discharge of Battery 15 15
Reset Problem 15 15
Disconnection 14 14
Tidal Volume Fluctuations 14 14
Device Sensing Problem 13 13
Device Alarm System 13 13
Activation Failure 12 12
Intermittent Loss of Power 12 12
No Apparent Adverse Event 11 11
Electrical Overstress 11 11
Device Tipped Over 10 10
Computer System Security Problem 9 9
Device Reprocessing Problem 9 9
Loss of Power 9 9
Excess Flow or Over-Infusion 8 8
Component Missing 8 8
Improper or Incorrect Procedure or Method 8 8
Failure to Calibrate 7 7
Complete Blockage 7 7
Erratic or Intermittent Display 7 7
Data Problem 7 7
Device Handling Problem 7 7
Noise, Audible 6 6
Degraded 6 6
No Device Output 6 6
Failure to Reset 6 6
Device-Device Incompatibility 6 6
Failure to Shut Off 5 5
Chemical Problem 5 5
Loss of Threshold 5 5
Defective Component 5 5
Incorrect Interpretation of Signal 5 5
Fire 5 5
Misassembly by Users 5 5
Ventilation Problem in Device Environment 4 4
Contamination 4 4
Inaccurate Flow Rate 4 4
Fluid/Blood Leak 4 4
Fracture 4 4
Human-Device Interface Problem 4 4
Moisture or Humidity Problem 4 4
Connection Problem 3 3
Device Damaged Prior to Use 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13455 13455
No Patient Involvement 2375 2411
No Consequences Or Impact To Patient 1170 1170
Insufficient Information 803 803
No Known Impact Or Consequence To Patient 205 480
Low Oxygen Saturation 90 90
Cardiac Arrest 22 22
Awareness during Anaesthesia 15 15
Death 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
No Information 7 7
Hypoxia 7 7
Cyanosis 6 6
Loss of consciousness 6 6
Vomiting 5 5
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
Unspecified Respiratory Problem 3 3
Convulsion/Seizure 2 2
Cough 2 2
Respiratory Arrest 2 2
Patient Problem/Medical Problem 2 2
Hypoventilation 2 6
Nausea 2 2
Coma 2 2
Cardiac Tamponade 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
Airway Obstruction 1 1
Arrhythmia 1 1
Burn(s) 1 1
Asystole 1 1
No Code Available 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Urinary Incontinence 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

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. II Jan-14-2022
2 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
3 GE Healthcare, LLC II Jul-20-2022
4 GE Healthcare, LLC I Jul-19-2022
5 GE Healthcare, LLC II Jun-24-2022
6 GE Healthcare, LLC II Sep-30-2021
7 GE Healthcare, LLC II Oct-30-2020
8 GE Healthcare, LLC I Jan-23-2020
9 GE Healthcare, LLC II Dec-17-2019
10 Getinge Group Logistics America, LLC II Mar-05-2021
11 Getinge Usa Sales Inc II Feb-06-2024
12 Getinge Usa Sales Inc I Jan-26-2023
13 Getinge Usa Sales Inc II Dec-07-2022
14 Getinge Usa Sales Inc I Jun-23-2022
15 Getinge Usa Sales Inc I Jan-10-2022
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