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 2018-06-21 for MONACO manufactured by Elekta Inc..
[112047485]
The investigation was completed by conducting a thorough evaluation of the product and the reported information. The issue could not be reproduced with data and information the customer has provided and it was not possible to determine if a malfunction occurred with the product. Investigation into potential workflow causes have been exhausted. Based on the information available a mistreatment occurred to a patient. The dose discrepancy for this particular patient was negligible as was determined by (b)(4) and corroborated by the customer site. If this same problem were to occur whilst treating another patient, it could go undetected and the dose difference could be larger potentially resulting in serious injury.
Patient Sequence No: 1, Text Type: N, H10
[112047486]
The customer reported that the plan exported from (b)(4) differs to what is being displayed by isodoses and dose volume histogram (dvh).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937649-2018-00009 |
| MDR Report Key | 7624623 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-21 |
| Date Mfgr Received | 2018-05-25 |
| Date Added to Maude | 2018-06-21 |
| 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 | 400 PERIMETER CENTER TERRACE SUITE 50 |
| Manufacturer City | ATLANTA GA 30346 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30346 |
| 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 | 2018-06-21 |
| 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 | 2018-06-21 |