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 |