FRESENIUS 2008K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-04-07 for FRESENIUS 2008K manufactured by Fresenius Usa, Inc.

Event Text Entries

[1576798] Follow up from cardiac arrest during dialysis. On functional test of dialysis machine following adverse event the machine eval failed alarm test.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1655773
MDR Report Key1655773
Report Source99
Date Received2010-04-07
Date of Report2010-04-05
Date of Event2010-03-27
Date Facility Aware2010-03-29
Report Date2010-04-05
Date Reported to FDA2010-04-06
Date Reported to Mfgr2010-04-06
Date Added to Maude2010-04-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFRESENIUS 2008K
Generic NameDIALYSIS MACHINE
Product CodeFKP
Date Received2010-04-07
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerFRESENIUS USA, INC
Manufacturer Address2637 SHADELANDS DR. WALNUT CREEK CA 94598 US 94598


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2010-04-07

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