MAUDE Adverse Event Report: MCKESSON MEDICAL IMAGING COMPANY HORIZON MEDICAL IMAGING; PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Model Number 11.8

Device Problems Application Program Problem (2880); Programming Issue (3014)

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

Event Date 04/25/2014

Event Type  malfunction  

Manufacturer Narrative

Mckesson completed an investigation and concluded that the root cause of the problem was a software defect.Mckesson found that the issue can only occur under the following circumstances: the pacs contains studies in the local cache storage, and the affected images/ studies were erroneously moved or deleted by a user, or have been lost due to an unrelated failure condition (e.G.Due to a defective or corrupt hard drive), and the lost studies have not been synchronized within the pacs system by mckesson support when images for a new study are subsequently received by pacs, the system may incorrectly re-use the disk location previously used by a study that has been affected by a prior data loss condition described above.As a result, two database records for two different studies may incorrectly index the same imaging study, leading to incorrect images being displayed for one of the patients.Mckesson will work with potentially affected customers to apply a software update to prevent the recurrence of the problem.

Event Description

Mckesson identified that 8 studies were missing on the short term storage location prior to performing a data migration.All 8 studies were previously reported.7 of these reported studies were determined to be lost and one study was identified as being indexed to an incorrect patient.No patient harm was reported as a result of this issue.

• Brand Name: HORIZON MEDICAL IMAGING
• Type of Device: PICTURE ARCHIVING AND COMMUNICATION SYSTEM
• Manufacturer (Section D): MCKESSON MEDICAL IMAGING COMPANY; 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• Manufacturer (Section G): MCKESSON MEDICAL IMAGING COMPANY; 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• Manufacturer Contact: paul sumner ; 5995 windward parkway; alpharetta, GA 30005 ; 4043383556
• MDR Report Key: 5434794
• MDR Text Key: 38165039
• Report Number: 8022257-2016-00001
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Model Number: 11.8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2012
• 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