MAUDE Adverse Event Report: MCKESSON MEDICAL IMAGING COMPANY HORIZON MEDICAL IMAGINING; PICTURE ARCHIVING AND COMM. SYSTEM

Model Number 11.8

Device Problems Computer Operating System Problem (2898); Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

The reported facility contacted mckesson to request assistance with an investigation into intermittent downtime of the horizon medical imaging (hmi) system for a specific workstation at the site.The site reported that a patient was kept under anesthesia 30 minutes longer than planned prior to th start of a surgical procedure.The workstation form the operating room was not able to connect to the hmi pacs system leading to images for the patient being unavailable.Someone from the radiology department retrieved the images on film from the radiology department.No patient being unavailable.Someone from the radiology department retrieved the images on film from the radiology department.No patient harm was reported.

Manufacturer Narrative

The reporting facility is multi-facility site.A satellite facility of the reporting facility needed a new workstation configured and mckesson support had inadvertently provided incorrect information during the configuration of the new workstation contained the incorrect user name and password for the new workstation at the satellite facility, the log-in information was for the reporting facility.When users log-in to the newly configured workstation and the log-on was authenticated, it brought down the hmi system at the reporting facility since the user name and password were used to log-in to another site.Both the facilities have confirmed to mckesson that they have resolved that they have resolved this issue by themselves by correcting the configuration.

• Brand Name: HORIZON MEDICAL IMAGINING
• Type of Device: PICTURE ARCHIVING AND COMM. SYSTEM
• Manufacturer (Section D): MCKESSON MEDICAL IMAGING COMPANY; richmond, b.c. ; CA
• Manufacturer Contact: naida marchant ; 130-10711 cambie road; richmond, b.c. V6X 3-G5 ; CA V6X 3G5 ; 6042795422
• MDR Report Key: 4384668
• MDR Text Key: 5122524
• Report Number: 8022257-2014-00014
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11.8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1