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987452

Medtronic Perfusion Systems — FEI 1000116158

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Brooklyn Park, MN (United States)

Facility

Other inspections at this facility

  • 1178299 (NAI Thu Jun 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886720 (NAI Tue Jun 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867900 (NAI Wed Feb 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 831904 (NAI Mon Apr 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 764709 (NAI Mon Jan 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
73221 CFR 803.50(a)(2)Individual Report of Malfunction