MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-25 for ICON 4348913 5227413 manufactured by Siemens Medical Systems, Inc. Nmg Group.
[82594]
Reinstallation of software causes user defined correction factors for the thyroid uptake and mag 3 programs to revert back to the mfr default factors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-1998-00005 |
| MDR Report Key | 189539 |
| Report Source | 05 |
| Date Received | 1998-09-25 |
| Date of Report | 1998-09-25 |
| Date of Event | 1998-08-28 |
| Date Mfgr Received | 1998-08-28 |
| Date Added to Maude | 1998-09-30 |
| 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 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON |
| Generic Name | COMPUTER |
| Product Code | JWM |
| Date Received | 1998-09-25 |
| Model Number | 4348913 |
| Catalog Number | 5227413 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 184193 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. NMG GROUP |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 601957372 US |
| Baseline Brand Name | ICON |
| Baseline Generic Name | NUCLEAR MEDICINE COMPUTER |
| Baseline Model No | 4348913 |
| Baseline Catalog No | 5227413 |
| Baseline ID | XB5211BJ3VX |
| 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 | 1998-09-25 |