MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PSA-NEMO, MANUAL, 4 AA BATTERIES; ACCESSORY

Model Number	EX3100
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure event observed during analysis.Final analysis revealed there was burn damage in the battery compartment.No batteries were received with the unit and internal visual inspection revealed no burn damage to the internal pcbas.
Event or Problem Description
This report is to advise of an event observed during analysis.

• Brand Name: PSA-NEMO, MANUAL, 4 AA BATTERIES
• Common Device Name: ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7820738
• Report Number: 2017865-2018-11668
• Device Sequence Number: 1573462
• Product Code: KRG
• UDI-Device Identifier: 05414734503105
• UDI-Public: 05414734503105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2018

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: Other
• Device Model Number: EX3100
• Device Catalogue Number: EX3100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2018
• Initial Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1