MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PWR CORD, HOS GR,IEC320; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	EE3000
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Prior to a procedure, the power conditioner power cable sparked when system was turned on.The conditioner was removed and system powered up normally.There was no patient involved in this event.
Additional Manufacturer Narrative
Additional information: d1, d10, g4, g7, h2, h3, h6 one hospital grade power cord pn 41-03089-001 was received into the lab for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event cannot be conclusively determined as no abnormalities were identified.All electrical contact pins and connector bodies are free of physical damage and discoloration due to electrical arcing.

• Brand Name: PWR CORD, HOS GR,IEC320
• 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: 9187431
• Report Number: 2184149-2019-00187
• Device Sequence Number: 3643508
• Product Code: DQK
• UDI-Device Identifier: 05415067014573
• UDI-Public: 05415067014573
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K141050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EE3000
• Device Catalogue Number: EE3000
• Device Lot Number: 5902000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1