MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-01-25 for MONACO manufactured by Elekta Inc..
[98307511]
Describe event or problem - updated. The investigation was completed by conducting a thorough evaluation of the product and the reported information. The reported problem was due to a defect in the software version that the customer was using (version 5. 00. 01). The issue was resolved in patch 5. 00. 03 which was available to the customer in (b)(6) 2015, however, the patch was not installed. This customer has now been upgraded to the newer version 5. 00. 04 on january 5, 2018. The investigation into this issue is complete.
Patient Sequence No: 1, Text Type: N, H10
[98307512]
The customer reported that patient was mistreated when exported using cfs option in (b)(6). Based on the available information there was a mistreatment but the severity would be negligible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937649-2018-00006 |
| MDR Report Key | 7218134 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-25 |
| Date Mfgr Received | 2018-01-02 |
| Date Added to Maude | 2018-01-25 |
| 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 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PMS |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | ELEKTA INC. |
| Manufacturer Street | 13723 RIVERPORT DRIVE SUITE 100 |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONACO |
| Generic Name | SYSTEM,PLANNING,RADIATION THERAPY TREATMENT |
| Product Code | MUJ |
| Date Received | 2018-01-25 |
| Operator | PHYSICIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INC. |
| Manufacturer Address | 13723 RIVERPORT DRIVE SUITE 100 MARYLAND HEIGHTS MO 63043 US 63043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-25 |