FDA Adverse Event
Other
Summary report: N
PRIMUS HI
MDR report key: 1002937
·
Received February 5, 2008
Report
- Report Number
- 2910081-2008-00009
- Event Type
- Other
- Date Received
- February 5, 2008
- Date of Event
- January 11, 2008
- Report Date
- January 14, 2008
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- IYE
- PMA / PMN Number
- K993425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ROOT CAUSE HAS NOT BEEN IDENTIFIED AND THE INVESTIGATION IS CURRENTLY ON GOING. ONCE THE INVESTIGATION IS COMPLETED, THE REGULATORY AGENCIES WILL BE NOTIFIED.
Description of Event or Problem · 1
WE ARE REPORTING THIS INCIDENT IN ABUNDANCE OF CAUTION. WE HAVE BECOME AWARE OF A MEDICAL LINEAR ACCELERATOR MALFUNCTION. A SERVICE ENGINEER RECEIVED AN ELECTRICAL SHOCK (120 VOLT AC) WHILE TROUBLESHOOTING AN ELECTRICAL ASSEMBLY INSIDE THE SYSTEM. THE ASSEMBLY HAD A LOOSE WIRE NEAR THE HIGH VOLTAGE INPUT. THE POWER WAS NOT DISABLED PRIOR TO THE INCIDENT. ROOT CAUSE HAS NOT BEEN IDENTIFIED AND THE INVESTIGATION IS CURRENTLY ON GOING. IT IS IMPORTANT TO NOTE THAT THE SERVICE ENGINEER HAS BEEN SEEN BY A MEDICAL STAFF AT THE MEDICAL FACILITY. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMUS HI | ACCELERATOR, LINEAR, MEDICAL | IYE | SIEMENS MEDICAL SOLUTIONS USA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |