MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-02-01 for MONACO manufactured by Elekta Inc..
[98781867]
The investigation was completed by conducting a thorough evaluation of the product and the reported information. (b)(4) have been unable to reproduce the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[98781868]
The customer reported that wrong dose-mu in segmented 3d plan. Based on the available information there has been an actual mistreatment which has led to serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937649-2018-00008 |
| MDR Report Key | 7234008 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-02-01 |
| Date of Report | 2018-02-01 |
| Date Added to Maude | 2018-02-01 |
| 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 | 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 | 2018-02-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2018-02-01 |