inforMED
OtherIZX

EUREKA LINEAR IIIP

Received May 21, 1998 · Event occurred Apr 1, 1998

Report 1423380-1998-00001 · MDR key 168953

Device

Generic name

Collimator

Manufacturer

Progeny, Inc.

Catalog number

70-53000P (PROGENY MODEL NO.)

Lot number

NA

Product problems

  • Disconnection

Patient

62 YR

  • Bruise/Contusion

Narrative

Description of Event or Problem

THE COLLIMATOR DISCONNECTED FROM THE X-RAY TUBE ASSEMBLY. THE COLLIMATOR IS ATTACHED TO THE X-RAY TUBE BY A COLLAR THAT LOCKS WITH A HINGED LOCKING MECHANISM. THE COLLAR HAS A SAFETY CATCH THAT IS ATTACHED BY A CAP SCREW AT THE TIME OF INSTALLATION. THE THREADS OF THE SCREW HAVE VIBRATITE, A REUSABLE THREAD LOCKING PRODUCT, APPLIED TO PREVENT THE SCREW FROM BACKING OUT DUE TO VIBRATION. THE PRODUCT IS SHIPPED WITH A RED WARNING NOTICE INSTRUCTING THE INSTALLER TO READ THE INSTALLATION INSTRUCTIONS. THESE INSTRUCTIONS DESCRIBE THE PROPER INSTALLATION OF THE SAFETY CATCH AND TO ONLY USE THE SCREW PROVIDED THAT HAS VIBRATITE. CO'S CONCLUSION IS THAT INSTALLER EITHER DID NOT INSTALL THE SAFETY CATCH PROPERLY OR USED THEIR OWN SCREW THAT DID NOT HAVE VIBRATITE.