MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-06-05 for GXDP-700 0.805.2001 manufactured by Palodex Group Oy.
[2765165]
During a routine follow-up phone call on (b)(6) 2012, to request additional information about the original complaint which was for "smell of smoke," the office reported that the unit caught fire.
Patient Sequence No: 1, Text Type: D, B5
[9925872]
The reported symptom of circuit failure and or burning circuitry could not be duplicated nor confirmed. Visual/physical examination accompanied by olfactory odor detection yielded no evidence of failed circuitry or components consistent with the reported symptoms of burning. A failure of the display was found. The reported symptom of gui display failure was confirmed. No pt involvement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005383085-2012-00001 |
| MDR Report Key | 2619735 |
| Report Source | 07 |
| Date Received | 2012-06-05 |
| Date of Report | 2012-05-31 |
| Date of Event | 2012-02-27 |
| Date Facility Aware | 2012-05-17 |
| Report Date | 2012-06-05 |
| Date Mfgr Received | 2012-02-27 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2012-06-18 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERHO TURKUMAKI, MANAGER |
| Manufacturer Street | NAHKELANTIE 160 |
| Manufacturer City | TUUSULA 04300 |
| Manufacturer Country | FI |
| Manufacturer Postal | 04300 |
| Manufacturer Phone | 503209113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GXDP-700 |
| Generic Name | ORTHOPANTOMOGRAPH OP300 |
| Product Code | MUH |
| Date Received | 2012-06-05 |
| Returned To Mfg | 2012-05-22 |
| Catalog Number | 0.805.2001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALODEX GROUP OY |
| Manufacturer Address | NAHKELANTIE 160 TUUSULA 04300 FI 04300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-05 |