MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-17 for DIAGNOSTIC ACHIVES 202-124-1 manufactured by Diagnostic Archives.
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According to the complainant, surgeon reportedly failed to complete a quadruple aortacoronary bypass on pt due to an alleged blank spot on a disk recorded in the catheterization lab. Thehe alleged blank spot was reportedly interpreted as the conclusion of the film supposedly leading to an anomalous circumflex artery not being bypassed. It is the allegation of the complaintant that this resulted in a massive myocardial infarction and the pt's death. The incident was not previously reported and is being forwarded at thisime by the attorney for the administrix of the estate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 66762-1995-09001 |
| MDR Report Key | 22584 |
| Date Received | 1995-03-17 |
| Date of Report | 1995-01-27 |
| Date of Event | 1993-01-18 |
| Date Facility Aware | 1995-01-23 |
| Report Date | 1995-01-27 |
| Date Reported to FDA | 1995-01-31 |
| Date Reported to Mfgr | 1995-01-31 |
| Date Added to Maude | 1995-06-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOSTIC ACHIVES |
| Generic Name | OPTICAL DISK |
| Product Code | LXJ |
| Date Received | 1995-03-17 |
| Model Number | 202-124-1 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22763 |
| Manufacturer | DIAGNOSTIC ARCHIVES |
| Manufacturer Address | 5516 COMMERCE DRIVE ORLANDO FL 32839 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1995-03-17 |