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 01/10/2014

Event Type  malfunction  

Event Description

A customer site reported that 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 pt injuries resultant form the reported alleged 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.Although the information was incorrectly displayed on the pae screen, the database storage and associated reports reflected the correct pt medical conditions data.The actual defect did not occur every time and was sporadic in nature.Further analysis determined that the malfunction was likely caused by as defect in the device software.There have been no adverse events or pt injuries resultant form the reported alleged malfunction.

• Brand Name: MCKESSON ANESTHESIA CARE
• Type of Device: MCKESSON ANESTHESIA CARE
• Manufacturer (Section D): MCKESSON TECHNOLOGIES, INC.; durham NC
• Manufacturer Contact: paul sumner ; 5995 winward parkway; alpharetta, GA 3005 ; 4043383556
• MDR Report Key: 3819046
• MDR Text Key: 18925943
• Report Number: 3009662297-2014-00004
• 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: Other
• Type of Report: Initial
• Report Date: 01/31/2014

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: 01/10/2014
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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