MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-24 for OPTIMA NM/CT 640 NMH970 manufactured by Ge Medical Systems Israel.
| Report Number | 9613299-2019-00004 |
| MDR Report Key | 9235392 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-24 |
| Date of Report | 2019-10-24 |
| Date of Event | 2019-09-25 |
| Date Mfgr Received | 2019-09-25 |
| Device Manufacturer Date | 2015-03-10 |
| Date Added to Maude | 2019-10-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN STRASSER |
| Manufacturer Street | 3000 N GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIMA NM/CT 640 |
| Generic Name | TOMOGRAPHY, COMPUTED, EMISSION |
| Product Code | JAK |
| Date Received | 2019-10-24 |
| Model Number | NMH970 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS ISRAEL |
| Manufacturer Address | FUNCTIONAL IMAGING 4 HAYOZMA ST. TIRAT HACARMEL 30200 IS 30200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-24 |