FRESENIUS 2008K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-10-30 for FRESENIUS 2008K manufactured by Fresenius Usa.

Event Text Entries

[15559091] Cracked housing on electrical plug.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5013298
MDR Report Key1520658
Date Received2009-10-30
Date of Report2009-10-30
Date Added to Maude2009-11-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFRESENIUS 2008K
Generic NameNONE
Product CodeFII
Date Received2009-10-30
Returned To Mfg2009-11-04
Model Number2008K
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerFRESENIUS USA
Manufacturer AddressWALNUT CREEK CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2009-10-30

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