MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ COMPUTER (HP Z600); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700096
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure, the computer shut down after a few minutes.A reboot was attempted multiple times with no resolution.The patient was prepped with local temporal sedation and catheters inserted.The procedure was cancelled and there were no patient consequences.
Additional Manufacturer Narrative
During device investigation, when the computer powered on, it shut off during booting of the operating system which confirmed the reported event.Further investigation revealed the issue was isolated to the power supply.The power supply was temporarily replaced with a known good unit.The computer powered on and displayed the software application.A read/write/ memory error was observed as the software application was initializing which indicated corrupted system files.Review of the system storage option rom revealed one of the hard drive had been degraded.This was due to an improper shut down which corrupted system files.Based on the information provided to abbott and the investigation performed, the reported event was confirmed.The root cause of the reported event was isolated to an intermittent power supply.

• Brand Name: EP-WORKMATE¿ COMPUTER (HP Z600)
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8094552
• Report Number: 2184149-2018-00186
• Device Sequence Number: 19295381
• Product Code: DQK
• UDI-Device Identifier: 05415067000965
• UDI-Public: 05415067000965
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H700096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other