FDA Adverse Event
Malfunction
Summary report: N
MOSAIQ
MDR report key: 7116387
·
Received December 14, 2017
Report
- Report Number
- 2950347-2017-00032
- Event Type
- Malfunction
- Date Received
- December 14, 2017
- Report Date
- February 21, 2018
- Manufacturer
- ELEKTA INC
- Product Code
- IYE
- UDI-DI
- 00858164002091
- PMA / PMN Number
- K141572
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.
Additional Manufacturer Narrative · 1
THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. CORRECTIONS AND ENHANCEMENTS HAVE BEEN CREATED SO THAT (B)(4) WOULD CHECK FOR ALL THE DATABASE ATTRIBUTES INVOLVED IN THE OVERRIDE'S OPERATION AND PROVIDE BETTER LOGGING INFORMATION FOR TROUBLESHOOTING THIS TYPE OF ISSUE. THEREFORE THIS IS NOT A SAFETY ISSUE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN ISSUE WITH MOSAIQ NOT RECORDING OVERRIDES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 898526 | MOSAIQ | ACCELERATOR, LINEAR, MEDICAL | IYE | ELEKTA INC | 00858164002091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |