MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-10 for ICON P/G3 5249177 * manufactured by Siemens Medical Systems.
[192512]
When creating composite file to use for the cardiac review program with a selection of rest/stress, the datasets are mislabeled on the composite page of the cardiac review program. Pt was misdiagnosed due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2000-00008 |
| MDR Report Key | 268404 |
| Report Source | 05 |
| Date Received | 2000-03-10 |
| Date of Report | 2000-03-09 |
| Date of Event | 2000-02-11 |
| Date Mfgr Received | 2000-02-11 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2000-03-14 |
| 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 Street | 2501 N BARRINGTON RD |
| Manufacturer City | HOFFMAN ESTATES IL 60195 |
| Manufacturer Country | US |
| Manufacturer Postal | 60195 |
| Manufacturer Phone | 8473047516 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON P/G3 |
| Generic Name | NUCLEAR MEDICINE COMPUTER |
| Product Code | JWM |
| Date Received | 2000-03-10 |
| Model Number | 5249177 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 259831 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60195 US |
| Baseline Brand Name | ICON P/G3 |
| Baseline Generic Name | NUCLEAR MEDICINE COMPUTER |
| Baseline Catalog No | 5249177 |
| Baseline ID | NA |
| Baseline Device Family | COMPUTER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K914350 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-03-10 |