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

Model Number MAC VERSION 15.1.1.2

Device Problems Computer Software Problem (1112); Data Problem (3196)

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

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed using a testing environment to determine the root cause of the reported event.The reported problem was reproducible only during intraop stage usage of the device (at the site) while live physiological data was being received.The anesthesia care record only displayed the inaccurate grid descriptor line, if the record was being edited during the receipt of measurement data.At this time, the reporting facility has been asked to adjust their physician work-flow steps not to edit the descriptions in the anesthesia care record during any phases where measurement data is received.A review of complaints revealed that this is the first complaint received for the reported event to date.Additionally, there have been no reported adverse health events or patient injuries resulting from this issue.

Event Description

A customer site reported the anesthesia care record accurately displayed the measurement data received.However, the anesthesia care record displayed the measurement data on the incorrect description line in the grid/graph when patient records were being edited by the reporting facility.There were no adverse events or patient harm resultant from the reported alleged malfunction.

• Brand Name: MCKESSON ANESTHESIA CARE
• Type of Device: MCKESSON ANESTHESIA CARE
• Manufacturer (Section D): MCKESSON TECHNOLOGIES, INC; 4813 emperor blvd suite 100; durham NC 27703
• Manufacturer (Section G): MCKESSON TECHNLOGIES, INC.; 4813 emperor blvd; suite 100; durham NC 27703
• Manufacturer Contact: paul sumner ; 5995 windward pwky; alpharetta, GA 30005 ; 4043383556
• MDR Report Key: 5192036
• MDR Text Key: 29973705
• Report Number: 3009662297-2015-00005
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/30/2015

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: MAC VERSION 15.1.1.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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