ICON 4348913 5227413

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-25 for ICON 4348913 5227413 manufactured by Siemens Medical Systems, Inc. Nmg Group.

Event Text Entries

[82594] Reinstallation of software causes user defined correction factors for the thyroid uptake and mag 3 programs to revert back to the mfr default factors.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423253-1998-00005
MDR Report Key189539
Report Source05
Date Received1998-09-25
Date of Report1998-09-25
Date of Event1998-08-28
Date Mfgr Received1998-08-28
Date Added to Maude1998-09-30
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 Received1998-09-25
Model Number4348913
Catalog Number5227413
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key184193
ManufacturerSIEMENS MEDICAL SYSTEMS, INC. NMG GROUP
Manufacturer Address2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 601957372 US
Baseline Brand NameICON
Baseline Generic NameNUCLEAR MEDICINE COMPUTER
Baseline Model No4348913
Baseline Catalog No5227413
Baseline IDXB5211BJ3VX
Baseline Device FamilyCOMPUTER
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK914350
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-09-25

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