MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER

Model Number	3120
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that during use of this programmer, the display screen suddenly went black and there was a notable burnt smell.No other physical anomalies with the unit however multiple restart/resets were unable to resolve the issues and the unit is expected to be returned for repair.There was no reported patient involvement.

• Brand Name: ZOOM LATITUDE
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• MDR Report Key: 10714224
• Report Number: 2124215-2020-21219
• Device Sequence Number: 3174173
• Product Code: LWS
• UDI-Device Identifier: 00802526564703
• UDI-Public: 00802526564703
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

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: 3120
• Device Catalogue Number: 3120
• Device Lot Number: 078172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1