MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ZOOM

Model Number	3120
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Event or Problem Description
Boston scientific received information that this programmer emitted smoke.The smoke came out of the floppy drive area and it smelled like hot electrical smoke.The programmer will be returned.There was no patient involvement reported.
Event or Problem Description
Boston scientific received information that this programmer emitted a white smoke which came out of the floppy drive area and it smelled like hot electrical smoke.The programmer will be returned.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this programmer was thoroughly inspected and analyzed.The programmer was confirmed to exhibit a product performance issue.The programmer was opened in order to assess the internal components.Detailed inspection identified an internal electrical component that had burned up and shorted out resulting in the reported clinical observations.Following repair of the unit, this programmer operated as expected.

• Brand Name: ZOOM
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7070250
• Report Number: 2124215-2017-20666
• Device Sequence Number: 16174614
• Product Code: LWS
• UDI-Device Identifier: 00802526582004
• UDI-Public: 00802526582004
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2018

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: Health Professional
• Device Model Number: 3120
• Other Device ID Number: ZOOM LATITUDE PROGRAMMER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/06/2017; 02/01/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/07/2018; 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1