MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-12-02 for ICON 5219527 manufactured by Siemens Medical Systems, Inc. Nmg Group.
[16145869]
Under certain conditions, the autoperfusion program may save incorrect data into the oblique file. This problem may be seen when processing gated spect data by itself or in conjunction with non-gated data.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-1998-00008 |
| MDR Report Key | 200865 |
| Report Source | 06 |
| Date Received | 1998-12-02 |
| Date of Report | 1998-11-12 |
| Date of Event | 1998-11-12 |
| Date Added to Maude | 1998-12-10 |
| 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 |
| Reporter Occupation | NUCLEAR MEDICINE TECHNOLOGIST |
| 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 | 1998-12-02 |
| Model Number | NA |
| Catalog Number | 5219527 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 195112 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. NMG GROUP |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60195 US |
| Baseline Brand Name | ICON |
| Baseline Generic Name | COMPUTER |
| Baseline Model No | NA |
| Baseline Catalog No | 5219527 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-12-02 |