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.
[21753280]
On (b)(6) 2012 while discussing a similar issue (see mdr (b)(4)), the dealer stated that he had heard that an "out of memory" error and reversed ct image failure had occurred at this location.
Patient Sequence No: 1, Text Type: D, B5
[21923215]
The dealer provided the serial number and address and contact info. Actual circumstances and details of the event are not yet known; we are investigating. The reported failure is similar to the issue reported in mdr 2530069-2012-00011. Investigation is underway.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530069-2012-00012 |
| MDR Report Key | 2645187 |
| Report Source | 08 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-06-29 |
| Date of Event | 2012-06-04 |
| Date Mfgr Received | 2012-06-04 |
| Device Manufacturer Date | 2010-08-13 |
| 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 Eval'ed by Mfgr | N |
| 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 |