MAUDE Adverse Event Report:; MEDICAL COMPUTERS AND SOFTWARE

Catalog Number UNKNOWN

Device Problem Computer Software Problem (1112)

Patient Problem No Information (3190)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

Users were unable to login to a select number of clinical workstations after an update/application was installed which allows users to reset their own passwords.Most notably, a cardiology computer providing clinical data to the cath lab was also impacted by the fix deployed to the aforementioned.Primarily class 1 type machines (which have a single sign on software) were impacted.In audition, a cardiology computer which acts like a server to provide data to the lab, and is running windows xp was misidentified as a class 1 machine and was also impacted.It should be noted that this software update has been rolling out in batches over the last three weeks without incident.There was no actual "software" that caused the problem.Rather, the issue was caused by the inadvertent deployment of a self-service password component that prevented login to the computer.The it department removed the offending component and rebooted the computer.

• Brand Name: UNK
• Type of Device: MEDICAL COMPUTERS AND SOFTWARE
• MDR Report Key: 3831895
• MDR Text Key: 4449814
• Report Number: 3831895
• Device Sequence Number: 1
• Product Code: LNX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2014
• Event Location: Other
• Date Report to Manufacturer: 05/27/2014
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 29