MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER

Model Number	3120
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a small puff of smoke came out from the programmer when powered on and burning smell was observed.No adverse effect was reported.The programmer was being returned.
Additional Manufacturer Narrative
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 (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: 15963970
• Report Number: 2124215-2022-52076
• Device Sequence Number: 4912660
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/12/2022

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: 062131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown