FDA Adverse Event
Malfunction
Summary report: N
MEVATRON KDS-2
MDR report key: 1013982
·
Received March 12, 2008
Report
- Report Number
- 2910081-2008-00015
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 6, 2008
- Report Date
- February 6, 2008
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS
- Product Code
- IYE
- PMA / PMN Number
- K862339
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT INVESTIGATION IS STILL ON GOING.
Description of Event or Problem · 1
IN THE ABUNDANCE OF CAUTION, THIS ISSUE IS BEING REPORTED TO THE REGULATORY AGENCY. A PRODUCT ISSUE HAS BEEN REPORTED WITH OUR MEDICAL LINEAR ACCELERATOR'S LEAD COUNTERWEIGHTS. THE LEAD COUNTERWEIGHTS (APPROXIMATELY 30-40KG) THAT WERE ATTACHED TO THE GANTRY STRUCTURE OPPOSITE FROM THE COLLIMATOR (BEAM LIMITING DEVICE) HAD COME LOOSE FROM ITS MOUNTING SCREWS. INVESTIGATION BY A SERVICE ENGINEER FOUND THAT THE MOUNTING SCREWS HAD SHEARED OFF. NO INJURY HAS BEEN REPORTED AS THE SURROUNDING GANTRY COVER RETAINED THE LOOSE LEAD COUNTERWEIGHTS. HOWEVER, IF MALFUNCTION WERE TO RECUR DURING SERVICE INTERVENTION WITH GANTRY COVERS REMOVED, POTENTIAL FOR SERIOUS INJURY IS POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEVATRON KDS-2 | ACCELERATOR, LINEAR, MEDICAL | IYE | SIEMENS MEDICAL SOLUTIONS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |