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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
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 the programmer was started, the screen did not light up and there was a smoke from the edge of the screen.Furthermore the programmer will be replaced and returned for repair/analysis.No adverse patient effect was reported.

• Brand Name: ZOOM LATITUDE
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• Manufacturer (Section G): CRS MEDICAL GMBH; loherstrasse 6; asslar 35614 ; GM 35614
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14164167
• Report Number: 2124215-2022-07489
• Device Sequence Number: 4293619
• Product Code: LWS
• UDI-Device Identifier: 00802526564703
• UDI-Public: 00802526564703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: Health Professional
• Device Model Number: 3120
• Device Catalogue Number: 3120
• Device Lot Number: 064952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown