MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ZOOM

Model Number	3120
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Problem with Software Installation (3013)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the programmer was performed.The programmer booted up to black screen with no backlight on.The inverter was shorted out on the lower half and the inverter cover was melted.The lcd (liquid crystal display) cover was also melted.There was no evidence of abuse or mishandling noted.Affected components were then replaced and the programmer passed all functional tests.
Event or Problem Description
Boston scientific received information that the field representative had a problem loading new software on the programmer and it then went black.It also smelled like plastic burning.The programmer was returned for evaluation, repaired, and is expected to be returned to the field.There was no patient involvement reported.

• Brand Name: ZOOM
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7168713
• Report Number: 2124215-2017-23153
• Device Sequence Number: 1823037
• Product Code: LWS
• UDI-Device Identifier: 00802526582004
• UDI-Public: 00802526582004
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/02/2017

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: 3120
• Other Device ID Number: ZOOM LATITUDE PROGRAMMER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1