MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-15 for GENERAL ELECTRIC 2197480 348C manufactured by General Electric.
[208410]
While sonographer was scanning with the ge 348c transducer they left a shocking sensation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 339398 |
| MDR Report Key | 339398 |
| Date Received | 2001-06-15 |
| Date of Report | 2001-06-07 |
| Date of Event | 2001-05-09 |
| Date Facility Aware | 2001-05-10 |
| Report Date | 2001-06-07 |
| Date Added to Maude | 2001-06-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENERAL ELECTRIC |
| Generic Name | ULTRASOUND SCANNER |
| Product Code | ITY |
| Date Received | 2001-06-15 |
| Returned To Mfg | 2001-06-01 |
| Model Number | 2197480 |
| Catalog Number | 348C |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 12 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 328724 |
| Manufacturer | GENERAL ELECTRIC |
| Manufacturer Address | 1111 N LOOP WEST #100 HOUSTON TX 77008 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-15 |