FDA Adverse Event Other Summary report: N

PICOM SOFTWARE

MDR report key: 642575 · Received October 18, 2005

Report

Report Number
642575
Event Type
Other
Date Received
October 18, 2005
Date of Event
October 7, 2005
Report Date
October 18, 2005
Manufacturer
SCIMAGE INC
Product Code
LMD
Report Source
User Facility report
Reporter Location
OH, US

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PICOM SOFTWARE COMPUTER IMAGING PROGRAM LMD SCIMAGE INC * *

Patients

Seq Age Sex Outcome Treatment
1 61 YR