ICON 5219527

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-03-16 for ICON 5219527 manufactured by Siemens Medical Systems, Inc. Nmg Group.

Event Text Entries

[21395449] Inconsistent results may occur while saving data twice on the processing page in the autoperfusion program.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423253-1999-00001
MDR Report Key215580
Report Source06
Date Received1999-03-16
Date of Report1999-02-16
Date of Event1999-02-01
Date Added to Maude1999-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location0
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameICON
Generic NameCOMPUTER
Product CodeJWM
Date Received1999-03-16
Model NumberNA
Catalog Number5219527
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key209121
ManufacturerSIEMENS MEDICAL SYSTEMS, INC. NMG GROUP
Manufacturer Address2501 N. BARRINGTON RD. HOFFMAN ESTATES IL 60195 US
Baseline Brand NameICON
Baseline Generic NameCOMPUTER
Baseline Model NoNA
Baseline Catalog No5219527
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-03-16

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