MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-28 for UMINOS AGILE MAX 10762472 manufactured by Siemens Healthcare Gmbh.
[140164759]
(b)(4). The investigation is on-going as the reported issue could not be reproduced by our technical experts. The log files were requested for further analysis. A supplemental report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[140164760]
Siemens became aware of unintended system movement of the luminos agile max device. The digital imaging tower (dit) moved without control in longitudinal direction. There are no injuries attributed to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2019-74531 |
| MDR Report Key | 8459688 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-13 |
| Date Facility Aware | 2019-03-19 |
| Report Date | 2019-03-19 |
| Date Reported to Mfgr | 2019-03-19 |
| Date Mfgr Received | 2019-05-09 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2019-03-28 |
| 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 | UMINOS AGILE MAX |
| Generic Name | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | JAA |
| Date Received | 2019-03-28 |
| Model Number | 10762472 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| 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 | 2019-03-28 |