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

Model Number MAC 15.0.4 VERSION

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

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

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed using a simulated testing environment to determine the root cause of the reported event.The results of the investigation concluded that incorrect information was displayed on the pae screens of the reporting facility after they changed the pae configuration and did not restart the service.Although the information was incorrectly displayed on the pae screen, the database storage and associated reports reflected the correct patient medical condition data.There have been no adverse events or patient injuries resultant form the reported alleged malfunction.

Event Description

A customer site reported that a medical history condition data on the medical history screen of the pre-anesthesia evaluation (pae) application did not reflect the correct conditions.There were no adverse events or patient injuries resultant from the reported alleged malfunction.

• Brand Name: MCKESSON ANESTHESIA CARE
• Type of Device: MCKESSON ANESTHESIA CARE
• Manufacturer (Section D): MCKESSON TECHNOLOGIES, INC.; 5995 windward parkway; alpharetta GA 30005
• Manufacturer (Section G): MCKESSON TECHNOLOGIES, INC.; 4813 emperor blvd; suite 100; durham NC 27703
• Manufacturer Contact: paul sumner ; 5995 windward parkway; alpharetta, GA 30005 ; 4043383556
• MDR Report Key: 5053773
• MDR Text Key: 24939334
• Report Number: 3009662297-2015-00004
• 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
• Report Date: 09/03/2015

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 15.0.4 VERSION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2013
• 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