FDA Adverse Event
Malfunction
Summary report: N
TOMOTHERAPY TREATMENT DELIVERY SYSTEM
MDR report key: 17862009
·
Received October 3, 2023
Report
- Report Number
- 3003873069-2023-00015
- Event Type
- Malfunction
- Date Received
- October 3, 2023
- Date of Event
- September 18, 2023
- Report Date
- September 25, 2024
- Manufacturer
- ACCURAY INCORPORATED
- Product Code
- IYE
- UDI-DI
- M65810182840
- PMA / PMN Number
- K121934
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE EVENT WAS DUE TO THE HARDWARE. IN ORDER TO RESOLVE THE ISSUE, THE CCA (COUCH CONTROL ASSEMBLY) WAS REPLACED. NO HARM WAS CAUSED TO THE PATIENT. THE RISK WAS DETERMINED TO BE ACCEPTABLE.
Additional Manufacturer Narrative · 0
CUSTOMER ALLEGED THE COUCH ROSE UP WITHOUT CCK (COUCH CONTROL KEYPAD) AND PCP (POSITIONING CONTROL PANEL) CONTROL AND NO ERROR RECORDED IN RDS (RADIATION DELIVERY SYSTEM)-LOG. THERE ARE NO KNOWN INJURIES.
Additional Manufacturer Narrative · 0
UDI RELATED DATA QUALITY UPDATES ONLY. PREVIOUSLY REPORTED UDI WAS FOUND TO BE INCORRECT DUE TO A COPY AND PASTE ISSUE IN SERVICE RECORD. THE CORRECTED UDI HAS BEEN ADDED TO FIELD D4 OF THIS REPORT.
Description of Event or Problem · 0
COUCH FAULT, CCK (COUCH CONTROL KEYPAD) COULD NOT STOP COUCH MOVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 588939 | TOMOTHERAPY TREATMENT DELIVERY SYSTEM | MEDICAL LINEAR ACCELERATOR | IYE | ACCURAY INCORPORATED | H-SERIES | M65810182840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |