MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-07-02 for I-CAT 0.830.4000 manufactured by Imaging Sciences International, Llc.
[15142970]
"the operator took the scan and just before the reconstruction completed, they got a "not enough memory" message. They pressed ok and the image came up. They did a workup and created a report, which they sent out. The surgeon rang them back pointing out that the image had been reversed. I have attached images. When they went to burn a cd they noticed there was no ct data, only raw. We then reconstructed and the pan was still reversed, but then it reverted to correct position a few moments later. "
Patient Sequence No: 1, Text Type: D, B5
[15277662]
The configuration consists of the i-cat imaging unit, pc workstation running visionq 1. 8. 1 imaging software connected in a pacs networked environment. The investigation determined that the raw ct data was present, but the ct image was missing in the study list generated by the software. The incident was reported to have been preceded by an "out of memory" error. The engineers investigating the "out of memory" error and reversed image were not able to duplicate the error/condition in the lab, we are therefore unable to confirm the complaint. No pt injury is associated with this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530069-2012-00011 |
| MDR Report Key | 2645018 |
| Report Source | 08 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-06-27 |
| Date of Event | 2012-06-04 |
| Date Mfgr Received | 2012-06-04 |
| Device Manufacturer Date | 2009-12-11 |
| Date Added to Maude | 2012-10-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH LAZARO |
| Manufacturer Street | 1910 NORTH PENN RD. |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer Phone | 2679540365 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-CAT |
| Generic Name | SYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL |
| Product Code | MUH |
| Date Received | 2012-07-02 |
| Catalog Number | 0.830.4000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMAGING SCIENCES INTERNATIONAL, LLC |
| Manufacturer Address | 1910 NORTH PENN RD. HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-02 |