MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-06-22 for ICON P SYSTEM G3 BLUE 5963744 * manufactured by Siemens Medical Systems, Inc., Ngm Group.
[20762750]
Loaded 3 review files into cardiac review-1 stress/rest, 1 gated rest only & 1 stress/rest if user selects the 1 study to display-ok, select the second (grest file)-ok. Select the third stress/rest study and the previous grest is display from the previous pt it does not update.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2000-00020 |
| MDR Report Key | 282976 |
| Report Source | 05,06 |
| Date Received | 2000-06-22 |
| Date of Report | 2000-06-22 |
| Date of Event | 2000-05-25 |
| Date Mfgr Received | 2000-05-25 |
| Date Added to Maude | 2000-06-26 |
| 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 | DALE LEHNER, DIR. |
| Manufacturer Street | 2501 N BARRINGTON ROAD |
| Manufacturer City | HOFFMAN ESTATES IL 60195 |
| Manufacturer Country | US |
| Manufacturer Postal | 60195 |
| Manufacturer Phone | 8473047700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON P SYSTEM G3 BLUE |
| Generic Name | COMPUTER |
| Product Code | JWM |
| Date Received | 2000-06-22 |
| Model Number | 5963744 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 273837 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC., NGM GROUP |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60195 US |
| Baseline Brand Name | ICON P/G3 |
| Baseline Generic Name | NUCLEAR MEDICINE COMPUTER |
| Baseline Model No | 5963744 |
| Baseline Catalog No | 5249177 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-06-22 |