FDA Adverse Event
Malfunction
Summary report: N
ONCOR EXPRESSION SYSTEM
MDR report key: 2501604
·
Received March 5, 2012
Report
- Report Number
- 2910081-2012-00014
- Event Type
- Malfunction
- Date Received
- March 5, 2012
- Date of Event
- February 8, 2012
- Report Date
- February 8, 2012
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY
- Product Code
- IYE
- PMA / PMN Number
- K060226
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SIEMENS US BECAME AWARE OF THE REPORTED EVENT ON (B)(4) 2012. THIS IS A KNOWN ISSUE THAT HAS BEEN SOLVED PER UI - (B)(4). THIS HAS BEEN IMPLEMENTED IN THE UNITED STATES HOWEVER NOT YET IN (B)(6) WHERE THE EVENT OCCURRED. THERE ARE EMERGENCY-OFF BUTTONS INSTALLED. ACCORDING TO THE USER MANUAL THE THERAPIST MUST SUPERVISE THE PT TREATMENT ALL THE TIME AND STOP ANY UNEXPECTED MOTION OF THE SYS BEFORE A PT IS INJURED BY MOVING PARTS.
Description of Event or Problem · 1
SIEMENS US WAS NOTIFIED ON (B)(4) 2012 THAT THE GANTRY MOVED WITHOUT ANY COMMAND FROM THE CUSTOMER, WITH HIGH RISK OF COLLISION WITH A PT OR THE MACHINE ITSELF. THERE IS NO REPORT OF INJURY TO A PT. THIS REPORTED EVENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONCOR EXPRESSION SYSTEM | ACCELERATOR, LINEAR, MEDICAL | IYE | SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY | 07360717 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |