MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-25 for CS8100 manufactured by Carestream Health, Inc..
[32144598]
Patient Sequence No: 1, Text Type: N, H10
[32144599]
The machine was installed by the vendor and the wiring from the machine to the visual cue (x-ray in use) was installed by an unknown contractor. When the machine was being adjusted for the patient, it seems to have pulled the energized wires away from the internal circuit board causing it to short. The electrical short caused smoke and sparks which were witnessed by the clinical team. Manufacturer response for carestream dental panorex x-ray machine, (brand not provided) (per site reporter): unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5249665 |
| MDR Report Key | 5249665 |
| Date Received | 2015-11-25 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-08-21 |
| Report Date | 2015-11-18 |
| Date Reported to FDA | 2015-11-18 |
| Date Reported to Mfgr | 2015-11-18 |
| Date Added to Maude | 2015-11-25 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CS8100 |
| Generic Name | SYSTEM,X-RAY,EXTRAORAL SOURCE,DIGITAL |
| Product Code | MUH |
| Date Received | 2015-11-25 |
| Model Number | CS8100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH, INC. |
| Manufacturer Address | 150 VERONA STREET ROCHESTER NY 14608 US 14608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-25 |