MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-05-19 for SUGMA SENSOR 55020 NA manufactured by Ge Healthcare Finland Oy.
[388853]
Following a test exposure, the sigma digital system displays only an image previously acquired. No patient associated with incident and no injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030852-2005-00003 |
| MDR Report Key | 604827 |
| Report Source | 08 |
| Date Received | 2005-05-19 |
| Date of Report | 2005-05-19 |
| Date of Event | 2005-04-18 |
| Date Mfgr Received | 2005-04-22 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2005-05-25 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY OVERLAND PHD, MANAGER |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W-400 |
| Manufacturer City | WAUKESHA WI * |
| Manufacturer Country | US |
| Manufacturer Postal | * |
| Manufacturer Phone | 2625482402 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer Street | P O BOX 20 NAHKELANTIE |
| Manufacturer City | TUUSLA 04301 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 04301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUGMA SENSOR |
| Generic Name | DENTAL |
| Product Code | EAP |
| Date Received | 2005-05-19 |
| Model Number | 55020 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 594614 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | NAHKELANTIE P.O. BOX 20 TUUSULA FI |
| Baseline Brand Name | SUGMA SENSOR |
| Baseline Generic Name | DENTAL |
| Baseline Model No | 55020 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-19 |