MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; PROGRAMMER

Model Number	3120
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned and analysis is performed, this report would be updated at that time.
Event or Problem Description
It was reported that this programmer emitted an audible noise and produced a burning smell upon start up.The programmer was then sent back for analysis.No patient involvement.

• Brand Name: ZOOM LATITUDE
• Common Device Name: PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• MDR Report Key: 11180476
• Report Number: 2124215-2020-25787
• Device Sequence Number: 3717635
• Product Code: LWS
• UDI-Device Identifier: 00802526564703
• UDI-Public: 00802526564703
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P910077/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2021

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
• Device Catalogue Number: 3120
• Device Lot Number: 053820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1