MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-08 for SYNGO VSIM 10830685 manufactured by Siemens Healthcare Gmbh.
[141239421]
(b)(4). Siemens has completed an investigation of the reported event. The root cause of the describer system behavior can be attributed to either the laser system not being commissioned, or more likely, the appropriate laser protocol was not used with the vsim system. If initial imaging is not performed, the intended treatment dose could be delivered to the wrong location, more than 10mm from the desired location. The investigation concluded that the vsim system did not malfunction. After checking the configuration, the setting was correctly repeated and a laser protocol was created. Afterwards, this protocol was used within the vsim and the marked position was correct. The investigation concluded the vsim system did not malfunction. The vsim application performs as specified. No further action is recommended at this time. Please note that this is a resubmission of the initial report, submitted on oct 26, 2018, due to a report code error.
Patient Sequence No: 1, Text Type: N, H10
[141239422]
It was reported to siemens that product problem occurred during operation of the syngo vsim system. The user stated that during the procedure, the reference point manager workflow of the syngo vsim application vsim laser coordinates were sometimes incorrect in the "in-out" direction. The user observed the deviation during imaging. There was no mistreatment of the patient or need for additional imaging. Although there was no patient injury during this event, mistreatment of a patient could occur if the user skips the imaging step at the beginning of the treatment delivery workflow. Due to the potential patient risk if this event were to reoccur, this complaint is being conservatively reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002466018-2018-50947 |
| MDR Report Key | 8492290 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-08 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-10-01 |
| Date Facility Aware | 2018-10-02 |
| Report Date | 2018-10-02 |
| Date Reported to Mfgr | 2018-10-02 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2019-04-08 |
| 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 | REBECCA TUDOR |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486484 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH |
| Manufacturer Street | ROENTGENSTRASSE 19-21 |
| Manufacturer City | KEMNATH, 95478 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 95478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNGO VSIM |
| Generic Name | SYSTEM, PLANNING, RADIATION THERAPY TREATMENT |
| Product Code | MUJ |
| Date Received | 2019-04-08 |
| Model Number | 10830685 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | ROENTGENSTRASSE 19-21 KEMNATH, 95478 GM 95478 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |