MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for ARTIS Q BIPLANE manufactured by Siemens Healthcare Gmbh.
[143239751]
The patient was brought down for a diagnostic angiogram. During the procedure the lateral image would become skewed. When doing a run, the screen would split in half and the bottom portion of the head would be on the top while the top portion of the head would be on the bottom of the screen. After performing the run the screen would flash on the lateral plane. There were two runs, trying different programs to see if that would help, that had significant delays in the lateral imaging. Half way through the case the attending physician opted to only use the ap plane for both ap and lateral images resulting in more radiation exposure and more contrast for the patient. Manufacturer response for siemens artis q biplane, artis q (per site reporter). Paged on call imaging person and came in to repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8554559 |
| MDR Report Key | 8554559 |
| Date Received | 2019-04-26 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-17 |
| Report Date | 2019-03-11 |
| Date Reported to FDA | 2019-03-11 |
| Date Reported to Mfgr | 2019-04-26 |
| Date Added to Maude | 2019-04-26 |
| 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 Q BIPLANE |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code | JAA |
| Date Received | 2019-04-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | 40 LIBERTY BOULEVARD MAILCODE: 65-1A MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-26 |