MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER

Model Number	3120
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when turning on the programmer it smelled like it was burning and was not able to boot up.Furthermore, the programmer will be replaced and returned for repair/analysis.No adverse patients effects were reported.
Event or Problem Description
It was reported that when turning on the programmer it smelled like it was burning and was not able to boot up.Furthermore, the programmer will be replaced and returned for repair/analysis.No adverse patients effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a visual evaluation of the programmer was performed.The allegation of this programmer based on the field report and the finding of smelled like it was burning and was not able to boot up was not confirmed.Analysis found the programmer had end of life.No additional adverse patients were reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZOOM LATITUDE
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11369675
• Report Number: 2124215-2021-03181
• Device Sequence Number: 3711740
• Product Code: LWS
• UDI-Device Identifier: 00802526564703
• UDI-Public: 00802526564703
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P910077/S046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2022

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: 081397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 02/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown