• 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 bassinet, hospital
Definition Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery.
Product CodeNZG
Regulation Number 880.5145
Device Class 2

MDR Year MDR Reports MDR Events
2017 7 7
2018 56 56
2019 5 7
2020 7 12
2021 3 3
2022 3 7

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 30 30
Device Operates Differently Than Expected 15 15
Material Deformation 7 7
Sharp Edges 7 15
Nonstandard Device 4 4
Break 3 3
Detachment Of Device Component 3 3
Inadequacy of Device Shape and/or Size 2 2
Material Integrity Problem 2 2
Device Slipped 2 2
Device Tipped Over 2 2
Use of Device Problem 1 1
Crack 1 1
Component Falling 1 1
Loose or Intermittent Connection 1 1
Connection Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Scratched Material 1 1
Device Fell 1 4
Unstable 1 1
Patient Device Interaction Problem 1 1
Material Separation 1 1
Bent 1 1
Material Disintegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 43 43
No Patient Involvement 12 17
No Code Available 10 10
No Clinical Signs, Symptoms or Conditions 7 13
No Information 2 2
Pain 2 2
No Consequences Or Impact To Patient 1 1
Physical Entrapment 1 1
Injury 1 1
Deformity/ Disfigurement 1 1
Fall 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Neuropathy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Division of Stryker Corporation II Feb-07-2019
-
-