MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-04 for MAGNETOM SOLA 11291455 manufactured by Siemens Healthcare Gmbh- Mr.
[186149564]
At the moment, we still assume a connection with the markers and not a malfunction. When using parallel imaging techniques the high signal from a marker close to a coil element cannot fully be resolved and ghosts may occur shifted by half of the fov in the accelerated encoding direction. In this situation, when using for example caipirinha sequences with a sliceshiftfactor and acceleration in 2 directions (slice and phase encoding direction), the folding artifacts may occur whose position is shifted by half of the field of view in 2 directions. This can be very difficult to identify since the appear not on the same slice in the original acquired, main orientation, and the artifact can easily be confused with a lesion. Siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a final root cause has not yet been determined. A supplement report will be filed upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[186149565]
It was reported to siemens that an adverse event occurred following examination on the magnetom sola system. It was reported that two patients received incorrect xray radiotherapy treatment due to misdiagnosis (positioning ball artifacts appears exactly the same as metastasis in the brain region image). At this time, we are unaware of any impact to the state of health of the patients involved. Siemens has requested additional information in order to conduct an investigation of the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2020-15121 |
| MDR Report Key | 9664259 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-04 |
| 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- MR |
| Manufacturer Street | HENKESTRASSE 127 |
| Manufacturer City | ERLANGEN, GERMANY 91052 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91052 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNETOM SOLA |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-02-04 |
| Model Number | 11291455 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH- MR |
| Manufacturer Address | HENKESTRASSE 127 ERLANGEN, GERMANY 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |