MAUDE Adverse Event Report: MCKESSON ISRAEL LTD.PANY MCKESSON CARDIOLOGY ECG MANAGEMENT

Model Number 13.1

Device Problems Computer Software Problem (1112); Loss of Data (2903); Data Problem (3196)

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

Event Date 09/29/2014

Event Type  malfunction  

Event Description

The reporting facility alleged that when an ecg procedure was sent to mckesson cardiology ecg management, the date and time of an existing procedure with the same accession number was updated although the new ecg procedure did not get imported.No patient harm has been reported.

Manufacturer Narrative

Mckesson's investigation determined that the root cause of the issue is a software defect.The date and time of an ecg procedure stored in mckesson cardiology ecg management is incorrectly updated when a procedure with the same accession number is received for the same patient.As designed, the second ecg procedure with the same accession number received is not imported and placed in the "failed import queue" for further review and correction by an end-user.However, no updates to the date and time of the pre-existing ecg procedure should be made in this instance.Mckesson will notify affected users of the issue and supply instructions (via safety notice) for identifying any potential affected ecg procedures.A software update to correct the problem in all affected versions of the software will be provided to affected users.

• Brand Name: MCKESSON CARDIOLOGY ECG MANAGEMENT
• Manufacturer (Section D): MCKESSON ISRAEL LTD.PANY; tel aviv ; IS
• Manufacturer Contact: paul sumner ; 5595 windward pkwy; alpharetta, GA 30005 ; 4043383556
• MDR Report Key: 4307108
• MDR Text Key: 5192644
• Report Number: 9616760-2014-00004
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Model Number: 13.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Patient Age: 101 YR