VANTAGE 9200-0411D-END NA

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 1999-08-27 for VANTAGE 9200-0411D-END NA manufactured by Adac Laboratories.

Event Text Entries

[183768] The m. D. Relied upon the vantage attenuation correction data, and as a consequence, misdiagnosed a patient. The patient did not receive cardiac catheterizaton, though it was later found to be necessary.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916556-1999-00149
MDR Report Key237648
Report Source06
Date Received1999-08-27
Date of Report1998-02-27
Date of Event1998-02-27
Date Mfgr Received1998-02-27
Date Added to Maude1999-08-31
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
Manufacturer ContactJANICE BROWN, DIRECTOR
Manufacturer Street540 ALDER DRIVE
Manufacturer CityMILPITAS CA 950357443
Manufacturer CountryUS
Manufacturer Postal950357443
Manufacturer Phone4084683766
Manufacturer G1ADAC LABORATORIES
Manufacturer Street540 ALDER DRIVE
Manufacturer CityMILPITAS CA 95035744
Manufacturer CountryUS
Manufacturer Postal Code95035 7443
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVANTAGE
Generic NameNUCLEAR MEDICINE EQUIPMENT
Product CodeIYY
Date Received1999-08-27
Model Number9200-0411D-END
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key230302
ManufacturerADAC LABORATORIES
Manufacturer Address540 ALDER DR. MILPITAS CA 950357443 US
Baseline Brand NameVANTAGE
Baseline Generic NameNUCLEAR MEDICINE EQUIPMENT
Baseline Model No9200-0411D-END
Baseline Catalog NoNA
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1999-08-27

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