DIAGNOST 76
Received Aug 31, 2007 · Event occurred Aug 1, 2007
Report 1217116-2007-00023 · MDR key 907119
Device
Generic name
Ixl - General Purpose R/f System
Manufacturer
Philips Medical SystemsModel number
9870-694-12172Catalog number
NA
Lot number
NA
Product problems
- Break
- Component Falling
- Fail-Safe Design Failure
Patient
NA YR
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem
THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MFR IN ANOTHER COUNTRY OF AN EVENT THAT OCCURRED IN THAT COUNTRY IN ANOTHER CITY. DURING A BREAK BETWEEN PATIENT EXAMS WITH THE SYSTEM IN STANDBY AND IN ITS UPRIGHT POSITION (+90 DEGREES) THE TOW STEEL BANDS SUPPORTING THE SERIAL CHANGER / COUNTERWEIGHT BROKE. THE CARRIAGE FELL DOWN, OVERRAN THE MECHANICAL END STOP AND FINALLY STOPPED ON THE FLOOR. NO INJURY OCCURRED SINCE THERE WERE NO PERSONS PRESENT IN THE ROOM.