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 2020-02-20 for MAGNETOM SYMPHONY SYNGO MR 7104594 manufactured by Siemens Healthcare Gmbh- Mr.
[188483303]
A siemens service engineer checked the system and confirmed that the system is operating within specification. The root cause was determined to be an operator error. In order to avoid such incidents in the future, always follow the instructions given in the operator manual regarding correct patient positioning. Assessment of the reported event does not indicate a system failure or malfunction and no non-conformity was identified. The operator manual provides clear instructions to carefully monitor the patient during table movement. No further actions are to be taken as there is no negative awareness in regards to the quality and performance of the mr system.
Patient Sequence No: 1, Text Type: N, H10
[188483304]
It was reported to siemens that an adverse event occurred while operating the magnetom symphony syngo mr system. An examination was performed on a (b)(6) male patient with a brain tumor and a low consciousness level. Following the examination, the operator removed the head coil and while the operator was turned, the patient fell from the table. The patient suffered a broken jaw which required emergency surgery. Siemens is unaware of the current state of health of the patient following surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2020-19224 |
| MDR Report Key | 9731853 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-20 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4486461 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNETOM SYMPHONY SYNGO MR |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-02-20 |
| Model Number | 7104594 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-20 |