inforMED
MalfunctionLMD

ACOM.NET

Received Jun 21, 2005 · Event occurred May 18, 2005

Report 2240869-2005-00016 · MDR key 729505

Device

Generic name

Medical Image Communication Device

Model number

5903872

Catalog number

*

Lot number

*

Product problems

  • No Display/Image
  • Device Damaged Prior to Use

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

A SCHEDULED PROCEDURE WAS CANCELLED BECAUSE THE USER FACILITY WAS UNABLE TO RETRIEVE THE FILES FROM THE PRIOR STUDY TO REVIEW. THE PRIOR STUDY HAD BEEN ARCHIVED IN DUPLICATE TO A TAPE LIBRARY, BUT THE RECORDED COPIES WERE DAMAGED AND NO LONGER AVAILABLE. THE USER FACILITY STATED THAT THE FIRST STUDY WOULD HAVE TO BE REPEATED IN ORDER TO DEFINE ANATOMY AGAIN.

Additional Manufacturer Narrative

ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. COMPUTER HARDWARE PERFORMANCE TESTS CONDUCTED. BUS CORRUPTION. SOFTWARE/FIRMWARE CONTRIBUTED TO EVENT.