inforMED
OtherLMD

PICOM SOFTWARE

Received Oct 18, 2005 · Event occurred Oct 7, 2005

Report 642575 · MDR key 642575

Device

Generic name

Computer Imaging Program

Manufacturer

Scimage Inc

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Image Display Error/Artifact

Patient

61 YR

  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

AFTER COMPLETION OF A LEFT HEART CATHETERIZATION, THE PHYSICIAN NOTIFIED STAFF THAT THE FILMS LABELED WITH THE PATIENT NAME WERE NOT PICTURES OF THAT PARTICULAR PATIENT. STAFF THEN CHECKED THE PICOM (COMPUTER INFORMATION SYSTEM) AND THE IMAGES PRESENT WERE THAT OF THE PREVIOUS CATHETERIZATION LAB PATIENT. APPARENTLY AFTER THE CARDIAC CATHETERIZATION WAS COMPLETED THE COMPUTERIZED TIME-BASED IMAGES SHOULD HAVE TRANSFERRED OVER TO ANOTHER SYSTEM FOR RETRIEVAL/STORAGE. ON THE PICOM IT APPEARED THAT THIS TRANSFER HAD OCCURRED AND AS PER PROTOCOL THE TECHNICIAN ERASED THE LOCAL IMAGES. AFTER NOTIFICATION BY THE PHYSICIAN, FURTHER INSPECTION REVEALED THAT THE TRANSFER DID NOT OCCUR SO THE PATIENT'S PICTURES WERE LOST (DUE TO TECH ERASURE). SUBSEQUENTLY, THE BIOMED DEPARTMENT WAS NOTIFED. OUR BIOMED DEPARTMENT CONTACTED THE COMPUTER PROGRAM COMPANY (SCIMAGE) TO SEE IF THE PATIENT'S IMAGES COULD BE RETRIEVABLE BY THEM(SCIMAGE). THE COMPUTER PROGRAM COMPANY (SCIMAGE) WAS UNABLE TO LOCATE THE PATIENT'S FILMS AND THE LEFT HEART CATH HAD TO BE REPEATED PER PHYSICIAN REQUEST. SINCE THE ERROR WAS NOTED PRIOR TO REMOVING ARTERIAL LINES WE HAD ACCESS FOR SECOND CATHETERIZATION. FAMILY AND PATIENT WERE INFORMED OF ERROR AND AGREED TO PROCEED WITH A SECOND LEFT HEART CATHETERIZATION.