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Center for Devices and Radiological Health, Food and Drug Administration Tina Powell

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Center for Devices and Radiological Health, Food and Drug Administration Tina Powell – PowerPoint PPT presentation

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Title: Center for Devices and Radiological Health, Food and Drug Administration Tina Powell


1
Center for Devices and Radiological Health,
Food and Drug AdministrationTina Powell CODA,
Inc.

2
CATEGORIZATION OF MedSun REPORTS
3
Top Ten Devices Reported to MedSun
4
Top Ten Contd
5
Most Common Problems Reported
1) Infusion Pump Use error 2)
Stapler Misfiring 3) Ventilator Stopped
working and/or delivering volume 4) IV
tubing Breakage 5) Electrosurgical
Unit Burns Problems with accessories
6
Most Common Problems Reported Contd
6) Stent, Coronary Development of
thrombosis 7) Infusion pump, PCA Multiple
failures 8) Catheter Material issues
Breakage and cracks 9) Defibrillator Compli
cations in discharge/ delivering shock 10)
Vascular closure device Would not seal
7
Total MedSun Reports Per Year and Cumulative
8
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