MAUDE Adverse Event Report: MCKESSON TECHNOLOGIES INC. MCKESSON ANESTHESIA CARE

Model Number MAX 15.X VERSIONS

Device Problems Computer Software Problem (1112); Computer Operating System Problem (2898); Operating System Becomes Nonfunctional (2996)

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

Event Date 01/22/2015

Event Type  malfunction  

Event Description

It was reported by one customer site of an alleged loss of data display between our company¿s software application and another vendor¿s physiological device.There were no adverse events of pt injuries resultant from the reported alleged malfunction.

Manufacturer Narrative

Upon investigation, it was determined that when the anesthesia care record (acr) application is installed on a workstation running (b)(4), the acr application will fail to retain case data if the user hovers his/her mouse over the notes (comments) pane, the messages pane, or the fluid intake/output screen and a tool tip is displayed.As a result, during this period of inactivity, case data from the physiological monitors are not recorded and case data updates received from other systems (via interfaces and integration) are not retained on the workstation.When the user¿s mouse is re-positioned, the application will return to its active state and begin to retain case data.The reporting hosp site was notified of the results of the investigation and the potential of the acr screen to become unresponsive and data to not record.Typically the acr application is used as touch-screen application where the mouse is rarely utilized.This event will not occur on a workstation when the user is using a touch-screen monitor without a mouse.There was no injury on the actual pt and/or no delay in pt care.

• Brand Name: MCKESSON ANESTHESIA CARE
• Type of Device: MCKESSON ANESTHESIA CARE
• Manufacturer (Section D): MCKESSON TECHNOLOGIES INC.; durham NC
• Manufacturer Contact: paul sumner ; 5995 windward pkwy; alpharetta, GA 3005 ; 4043383556
• MDR Report Key: 4465600
• MDR Text Key: 20125930
• Report Number: 3009662297-2015-00001
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAX 15.X VERSIONS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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