Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BENCHMARK ZOOM LATITUDE; EXTERNAL PROGRAMMER Back to Search Results
Model Number 3120
Medical Device Problem Codes Defective Device (2588); Device Displays Incorrect Message (2591); Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
 
Event or Problem Description
It was reported that this programmer exhibited frozen screen and displayed error codes.Troubleshooting was done but unsuccessful.In addition, the programmer emitted slight smell of burning electronics.The programmer will be returned.No patient involvement was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZOOM LATITUDE
Common Device Name
EXTERNAL PROGRAMMER
Manufacturer (Section D)
BENCHMARK
4065 theurer boulevard
winona MN 55987
MDR Report Key10714373
Report Number2124215-2020-21008
Device Sequence Number16937544
Product Code LWS
UDI-Device Identifier00802526564703
UDI-Public00802526564703
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P910077/S046
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/21/2020
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 Number3120
Device Catalogue Number3120
Device Lot Number058733
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/24/2020
Initial Report FDA Received Date10/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-