MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for ARTIS VD 11C manufactured by Siemens Medical Solutions Usa, Inc..
[177966526]
At 09:11 hours, ipp9 sent an error message to the monitors of: "limited table/stand movement". The table and ap flat detector moved significantly slow like it was in collision mode. All of the resets were complete with troubleshooting the room and the error did not clear. At this time, clinical imaging was in the core and witnessed with issue. A hard shut down and reboot of the room was then completed. The error still didn't clear, and the physician could not proceed with the procedure in ipp9. The intubated patient was then moved to another room for completion of the procedure. A service call was placed to siemen's and the service clinician came to assess the room. Manufacturer response for system, x-ray, fluoroscopic, image-intensified, (artis vd 11c) (per site reporter). The rep from siemens has not arrived yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9676042 |
| MDR Report Key | 9676042 |
| Date Received | 2020-02-06 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-13 |
| Report Date | 2019-12-16 |
| Date Reported to FDA | 2019-12-16 |
| Date Reported to Mfgr | 2020-02-06 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTIS VD 11C |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code | JAA |
| Date Received | 2020-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 40 LIBERTY BOULEVARD MAILCODE: 64-1A MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |