MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-23 for LUMINOS AGILE MAX 10762472 manufactured by Siemens Healthcare Gmbh.
[142797983]
Resubmission of initial report as per fda on 4/3/2019. Investigation of the incident is on-going. A supplemental report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[142797984]
Siemens became aware of an incident with the luminos agile max system. It was reported that two x-ray technicians hurt themselves on a sharp corner of the wall stand. No further details of the incident or medical treatment have been provided to siemens. There is no patient involvement in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2019-67739 |
| MDR Report Key | 8541103 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-23 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-06-14 |
| Date Added to Maude | 2019-04-23 |
| 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 | 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 HEALTHCARE GMBH |
| Manufacturer Street | SIEMENSSTR.1 |
| Manufacturer City | FORCHHEIM, 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMINOS AGILE MAX |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | JAA |
| Date Received | 2019-04-23 |
| Model Number | 10762472 |
| 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 HEALTHCARE GMBH |
| Manufacturer Address | SIEMENSSTR.1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-23 |