FDA Adverse Event
Malfunction
Summary report: N
ELEKTA INFINITY
MDR report key: 20188519
·
Received September 11, 2024
Report
- Report Number
- 3015232217-2024-00029
- Event Type
- Malfunction
- Date Received
- September 11, 2024
- Report Date
- January 10, 2025
- Manufacturer
- ELEKTA SOLUTIONS AB
- Product Code
- IYE
- UDI-DI
- 05060191071512
- PMA / PMN Number
- K210500
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DUE TO AN ADMINISTRATIVE ERROR, THE INITIAL REPORT WAS SUBMITTED UNDER THE WRONG MANUFACTURER AND THEREFORE AN INVALID MFR NUMBER. NO FURTHER REPORTS WILL BE SENT AGAINST THIS MFR NUMBER (3015232217-2024-00029). A CORRECTED REPORT WILL BE SUBMITTED UNDER 9617016-2024-00004.
Additional Manufacturer Narrative · 0
THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.
Description of Event or Problem · 0
THE CUSTOMER REPORTED THAT THEY BELIEVE EXCESS DOSE IS BEING DELIVERED TO THE PATIENT BEFORE THE BEAM TERMINATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537990 | ELEKTA INFINITY | ACCELERATOR, LINEAR, MEDICAL | IYE | ELEKTA SOLUTIONS AB | 05060191071512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |