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 2020-02-21 for MOSAIQ manufactured by Elekta Inc.
[181170043]
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Patient Sequence No: 1, Text Type: N, H10
[181170044]
The customer reported a field change prior to treatment delivery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950347-2020-00007 |
| MDR Report Key | 9738827 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| 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 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOSAIQ |
| Generic Name | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | IYE |
| Date Received | 2020-02-21 |
| 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 | 100 MATHILDA PLACE 5TH FLOOR SUNNYVALE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |