MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-03-14 for GE MEDICAL SYSTEMS, IT 0128AAN NA manufactured by Ge Medical Systems Information Technologies.
[315568]
Customer reported unit smoked while in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124823-2003-00014 |
| MDR Report Key | 448599 |
| Report Source | 07 |
| Date Received | 2003-03-14 |
| Date of Report | 2003-03-13 |
| Date of Event | 2002-08-05 |
| Date Added to Maude | 2003-03-20 |
| 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 |
| Manufacturer Contact | ANNIE BODE |
| Manufacturer Street | 8200 W. TOWER AVE. |
| Manufacturer City | MILWAUKEE WI 53223 |
| Manufacturer Country | US |
| Manufacturer Postal | 53223 |
| Manufacturer Phone | 4143622368 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE MEDICAL SYSTEMS, IT |
| Generic Name | FETAL MONITOR |
| Product Code | KNG |
| Date Received | 2003-03-14 |
| Model Number | 0128AAN |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 437582 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Manufacturer Address | 8200 WEST TOWER AVE. MILWAUKEE WI 53223 US |
| Baseline Brand Name | GE MEDICAL SYSTEMS, IT |
| Baseline Generic Name | FETAL MONITOR |
| Baseline Model No | 0128AAN |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-03-14 |