MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-06-17 for * 46-262781G2 manufactured by Ge Medical Systems, Llc.
[380431]
It was reported that the rfx spot film device (spd) carriage fell off the tower when the doctor was moving it into the operating position. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2004-00009 |
| MDR Report Key | 597884 |
| Report Source | 05 |
| Date Received | 2004-06-17 |
| Date of Report | 2004-06-17 |
| Date of Event | 2004-05-17 |
| Date Mfgr Received | 2004-05-17 |
| Date Added to Maude | 2005-05-03 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY OVERLAND, PH.D.(MANAGER) |
| Manufacturer Street | 3000 NORTH GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482402 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Street | 3000 NORTH GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53188 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | IXL |
| Date Received | 2004-06-17 |
| Model Number | 46-262781G2 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 587717 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 NORTH GRANDVIEW BLVD. WAUKESHA WI 53188 US |
| Baseline Brand Name | * |
| Baseline Generic Name | DIAGNOSTIC X-RAY |
| Baseline Model No | 46-262781G2 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-17 |