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.
[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
Report Number | 2916556-1999-00149 |
MDR Report Key | 237648 |
Report Source | 06 |
Date Received | 1999-08-27 |
Date of Report | 1998-02-27 |
Date of Event | 1998-02-27 |
Date Mfgr Received | 1998-02-27 |
Date Added to Maude | 1999-08-31 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | JANICE BROWN, DIRECTOR |
Manufacturer Street | 540 ALDER DRIVE |
Manufacturer City | MILPITAS CA 950357443 |
Manufacturer Country | US |
Manufacturer Postal | 950357443 |
Manufacturer Phone | 4084683766 |
Manufacturer G1 | ADAC LABORATORIES |
Manufacturer Street | 540 ALDER DRIVE |
Manufacturer City | MILPITAS CA 95035744 |
Manufacturer Country | US |
Manufacturer Postal Code | 95035 7443 |
Single Use | 3 |
Remedial Action | NO |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VANTAGE |
Generic Name | NUCLEAR MEDICINE EQUIPMENT |
Product Code | IYY |
Date Received | 1999-08-27 |
Model Number | 9200-0411D-END |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 230302 |
Manufacturer | ADAC LABORATORIES |
Manufacturer Address | 540 ALDER DR. MILPITAS CA 950357443 US |
Baseline Brand Name | VANTAGE |
Baseline Generic Name | NUCLEAR MEDICINE EQUIPMENT |
Baseline Model No | 9200-0411D-END |
Baseline Catalog No | NA |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 1999-08-27 |