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

Model Number MAC 15.0.4 VERSION

Device Problems Computer Software Problem (1112); Patient Data Problem (3197)

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

Event Date 05/14/2015

Event Type  malfunction  

Event Description

It was reported by one customer site of an occurrence where the data displayed in the patient demographic section of the anesthesia care record (acr) changed in the middle of the patient case, and the new patient demographic information did not match the actual patient.There was no adverse events or patient injuries resultant from the reported alleged malfunction.

Manufacturer Narrative

The company was unable to duplicate the alleged problem or determine root cause.Further investigation conducted by the software development team determined that there is no indication that the device malfunctioned; however, a plausible explanation of the errors in the data displayed on the workstation indicated that it was likely caused by an erroneous interface message received form an outside source.It is believed that all information displayed was correct at the start of the procedure, an interface message received form another source caused the override of the patient demographic information.In this event, the patient demographic information affected was the patient name, sex, and date of birth.The reporting hospital/site was notified of the results of the investigation and the site was able to rectify the case xml, patient data and applicable reports.The company will continue to investigate.This is the first reported occurrence of this event.There was no injury to the actual patient and/or no delay in patient 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 30005
• MDR Report Key: 4828312
• MDR Text Key: 5903062
• Report Number: 3009662297-2015-00002
• 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: 06/03/2015

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: 05/14/2015
• Initial Date FDA Received: 06/04/2015
• 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