VISION POWERSTATION VISON POWERSTATION FP 201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-05 for VISION POWERSTATION VISON POWERSTATION FP 201 manufactured by Smv America.

Event Text Entries

[36041] After mibi myocard reconstruction, the customer thinks that there is a difference between the both reconstructed volumes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1528274-1996-00025
MDR Report Key54222
Date Received1996-12-05
Date of Report1996-11-26
Date of Event1996-09-27
Date Facility Aware1996-10-18
Report Date1996-11-26
Date Reported to Mfgr1996-11-26
Date Added to Maude1996-12-10
Event Key0
Report Source CodeDistributor 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 Code0
Event Type3
Type of Report3

Device Details

Brand NameVISION POWERSTATION
Generic NameCOMPUTER
Product CodeJWM
Date Received1996-12-05
Model NumberVISON POWERSTATION
Catalog NumberFP 201
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age12 MO
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key54794
ManufacturerSMV AMERICA
Manufacturer Address8380 DARROW RD TWINSBURG OH 44087 US


Patients

Patient NumberTreatmentOutcomeDate
10 1996-12-05

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