MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-12 for MOBILETT ELARA MAX 11107444 manufactured by Siemens S.a..
| Report Number | 1000342169-2019-91880 |
| MDR Report Key | 8884430 |
| Date Received | 2019-08-12 |
| Date of Report | 2019-08-07 |
| Date of Event | 2019-08-05 |
| Date Mfgr Received | 2019-10-24 |
| Date Added to Maude | 2019-08-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANASTASIA SOKOLOVA |
| Manufacturer Street | 40 LIBERTY BLVD, MC 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486478 |
| Manufacturer G1 | SIEMENS S.A. |
| Manufacturer Street | PARQUE EMPRESARIAL LA CARPETAN AVENIDA LEONARDO DA VINCI, 15 |
| Manufacturer City | 28906 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILETT ELARA MAX |
| Generic Name | MOBILE X-RAY SYSTEM |
| Product Code | IZL |
| Date Received | 2019-08-12 |
| Model Number | 11107444 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS S.A. |
| Manufacturer Address | PARQUE EMPRESARIAL LA CARPETAN AVENIDA LEONARDO DA VINCI, 15 28906 SP 28906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-12 |