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 |