MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-04-29 for AXIOM LUMINOS TF 10093902 manufactured by Siemens Healthcare Gmbh, Advanced Therapies.
[143422268]
The log files from the reported incident were deleted and the engineer has been unable to duplicate the situation. The investigation of the reported issue is on-going. A supplemental report will submitted if additional information becomes available. This report was submitted april 26, 2017.
Patient Sequence No: 1, Text Type: N, H10
[143422269]
It was reported that during an exam the axiom luminos tf system started beeping fast and intermittently. An unintended system movement was reported as well. The system tilted on its own for several seconds before stopping. The operator waited for this behaviour to end and then completed the exam without further incidents. There are no injuries attributed to this event. According to siemens engineer, who inspected the system, no one was touching the system controls during the incident. The customer was advised to push the emergency stop bottom to stop all system movements in case of another incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2017-76899 |
| MDR Report Key | 8560202 |
| Report Source | FOREIGN |
| Date Received | 2019-04-29 |
| Date of Report | 2017-04-07 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-04-07 |
| Date Added to Maude | 2019-04-29 |
| 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 | MEREDITH ADAMS |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486461 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES |
| Manufacturer Street | SIEMENSSTRASSE 1 |
| Manufacturer City | FORCHHEIM, GERMANY 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIOM LUMINOS TF |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code | JAA |
| Date Received | 2019-04-29 |
| Model Number | 10093902 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES |
| Manufacturer Address | SIEMENSSTRASSE 1 FORCHHEIM, GERMANY 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-29 |