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

Model Number 11.9

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/04/2015

Event Type  Death  

Manufacturer Narrative

In response to the request from the reporting facility, mckesson initiated an investigation in order to determine when the nm study was reviewed by the technologist.Mckesson investigation of the system logs indicate that the nm study performed on (b)(6) 2015 at 18:10 was marked as reviewed by the technologist on (b)(6) 2015 at 10:13.The nm study was reported by a radiologist on (b)(6) 2015 at 13:05.Based on the investigation performed and analysis of the application logs, there is no evidence of a device malfunction.

Event Description

It was reported by the customer site that on (b)(6) 2015, a patient was imaged for a nuclear medicine (nm) study at 18:10.The patient expired on (b)(6) 2015 at 21:50.On (b)(6) 2015, the customer site clinical imaging administrator contacted mckesson requesting assistance, in determining,through the review of the pacs logs, the date and time the nm study was reviewed by the performing technologist and moved to the radiologist's worklist for diagnosis.

• 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 MEDIAL IMAGING COMPANY; 130 - 10711 cambie road; richmond, british columbia V6X 3 G5; CA V6X 3G5
• Manufacturer Contact: nadia marchant ; 130-10711 cambie road; richmond, british columbia V6X 3-G5 ; CA V6X 3G5 ; 2795422
• MDR Report Key: 5040335
• MDR Text Key: 24519792
• Report Number: 8022257-2015-00005
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11.9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2012
• 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
• Patient Outcome(s): Death
• Patient Age: 59 YR