MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-29 for OPTIMA 220R MDL 5331287 * manufactured by Ge Medical Systems, Llc.
[3045096]
When placing the dr cassette under a patient for chest or abdominal x-ray using the manufacturer's recommended method (handle), the imaging staff quite frequently, inadvertently presses the power button located on the handle of the device. This delays the procedure as the cassette must be powered back on and reinitialized. Other methods of inserting the cassette are awkward and require two hands. Placement of the unprotected power switch should be reconsidered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2839336 |
| MDR Report Key | 2839336 |
| Date Received | 2012-10-29 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-07-31 |
| Report Date | 2012-08-02 |
| Date Reported to FDA | 2012-10-29 |
| Date Added to Maude | 2012-11-20 |
| 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 | OPTIMA 220R |
| Generic Name | X-RAY, DR CASSETTE |
| Product Code | IXL |
| Date Received | 2012-10-29 |
| Model Number | MDL 5331287 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3200 NORTH GRANDVIEW BOULEVARD WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-29 |