MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; PROGRAMMER

Model Number	3120
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
Event or Problem Description
It was reported that this programmer heated up and melted.The programmer was returned.There was no report of patient involvement.

• Brand Name: ZOOM LATITUDE
• Common Device Name: PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• MDR Report Key: 9667947
• Report Number: 2124215-2020-02532
• Device Sequence Number: 2667760
• Product Code: LWS
• UDI-Device Identifier: 00802526575303
• UDI-Public: 00802526575303
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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: Other
• Device Model Number: 3120
• Device Catalogue Number: 3120
• Device Lot Number: 070946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1