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.
[114870]
In autoperfusion program, load a gated stress and non-gated rest study. If save obliques option is used when the gated data is displayed the saved non-gated rest file does not contain the rest data of time bin four.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-1998-00007 |
| MDR Report Key | 200863 |
| Report Source | 06 |
| Date Received | 1998-12-02 |
| Date of Report | 1998-11-10 |
| Date of Event | 1998-11-10 |
| 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 |
| 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 | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 195111 |
| 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 |