MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER

Model Number	3120
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Product not yet returned for analysis.
Event or Problem Description
It was reported that 3120 programmer blew up when attempting to turn on.Furthermore the programmer will be replaced and returned for repair/analysis.No patient involvement was reported.

• Brand Name: ZOOM LATITUDE
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BENCHMARK; 4065 theurer boulevard; winona MN 55987
• MDR Report Key: 12481613
• Report Number: 2124215-2021-24274
• Device Sequence Number: 11984846
• Product Code: LWS
• UDI-Device Identifier: 00802526564703
• UDI-Public: 00802526564703
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/16/2021

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: 075940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 09/16/2021
• Patient Sequence Number: 1