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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, tubing and support, ventilator (w harness)
Product CodeBZO
Regulation Number 868.5975
Device Class 1

MDR Year MDR Reports MDR Events
2014 84 84
2015 55 55
2016 56 56
2017 46 46
2018 26 26
2019 33 33
2020 30 30
2021 52 52
2022 66 66
2023 37 37
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 105 105
Break 78 78
Disconnection 36 36
Device Issue 29 29
Leak/Splash 28 28
Crack 28 28
Hole In Material 26 26
Gas/Air Leak 21 21
Device Operates Differently Than Expected 19 19
Split 19 19
Detachment of Device or Device Component 17 17
Detachment Of Device Component 16 16
Mechanical Problem 13 13
Connection Problem 11 11
Fracture 11 11
Torn Material 11 11
Fitting Problem 10 10
Failure of Device to Self-Test 9 9
Material Integrity Problem 8 8
Loose or Intermittent Connection 7 7
Insufficient Information 6 6
Material Puncture/Hole 5 5
Air Leak 5 5
Inadequacy of Device Shape and/or Size 5 5
Device Displays Incorrect Message 4 4
Device Handling Problem 4 4
Nonstandard Device 3 3
Defective Component 3 3
Device Dislodged or Dislocated 3 3
Physical Property Issue 3 3
Device Damaged Prior to Use 3 3
Device Contamination with Chemical or Other Material 3 3
Material Too Rigid or Stiff 3 3
Use of Device Problem 3 3
Material Separation 3 3
Gas Output Problem 2 2
Melted 2 2
Infusion or Flow Problem 2 2
Obstruction of Flow 2 2
Component Missing 2 2
Material Twisted/Bent 2 2
Stretched 2 2
Failure to Deliver 2 2
Overheating of Device 2 2
Defective Device 2 2
Collapse 2 2
Material Disintegration 2 2
Device Slipped 2 2
Improper Flow or Infusion 1 1
Out-Of-Box Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 149 149
No Patient Involvement 112 112
No Consequences Or Impact To Patient 101 101
No Known Impact Or Consequence To Patient 95 95
Low Oxygen Saturation 19 19
Insufficient Information 13 13
No Information 6 6
Bradycardia 6 6
Decreased Respiratory Rate 4 4
Skin Erosion 3 3
Hypoventilation 2 2
No Code Available 2 2
Pulmonary Insufficiency 2 2
Foreign Body In Patient 2 2
Hemorrhage/Bleeding 2 2
Cyanosis 1 1
Patient Problem/Medical Problem 1 1
Apnea 1 1
Death 1 1
Respiratory Distress 1 1
Not Applicable 1 1
Chest Tightness/Pressure 1 1
Cardiac Arrest 1 1
Respiratory Acidosis 1 1
Burn(s) 1 1
Rash 1 1
Injury 1 1
Erythema 1 1
Anoxia 1 1
Scar Tissue 1 1
Cough 1 1
Hypoxia 1 1
Therapeutic Effects, Unexpected 1 1
Sore Throat 1 1
Ventilator Dependent 1 1
Tissue Breakdown 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. I May-17-2023
2 Draeger Medical, Inc. II Apr-10-2014
3 Fisher & Paykel Healthcare, Ltd. I May-20-2014
4 Fisher & Paykel Healthcare, Ltd. I Jan-03-2013
5 Hamilton Medical, Inc. II Jul-02-2015
6 Mallinckrodt Manufacturing LLC I Sep-09-2023
7 TELEFLEX MEDICAL INC II May-24-2022
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