MalfunctionLMB
IMPAX
Received Oct 20, 1998 · Event occurred Sep 18, 1998
Report MW1014781 · MDR key 192722
Device
Generic name
Dicom Image Archive
Manufacturer
Bayer Corp. Afga DivisionModel number
AS 3000Catalog number
*
Lot number
*
Product problems
- Computer Software Problem
Patient
*
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
OPTICAL DISK DRIVE IN DICOM IMAGE ARCHIVE DAMAGED DISKS SO THAT FILES WERE UNREADABLE AND UNRECOVERABLE. THESE WERE FACILITIES ONLY COPIES OF PT IMAGES. THE DATA LOSS PLACES FACILITY IN NON-COMPLIANCE WITH STATE LAWS REGARDING RECORD RETENTION. FURTHERMORE, SEVERAL PTS HAVE NOT BEEN ABLE TO ACCESS THEIR MEDICAL RECORDS FOR THE PRUPOSES OF A SECOND OPINION. DUE TO THE DATA BEING NON-RETREIVABLE.