BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICOUNTER

    MDR report key: 3522240 · Received September 26, 2013

    Report

    Report Number
    3522240
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    August 30, 2013
    Report Date
    September 26, 2013
    Manufacturer
    SURGICOUNT MEDICAL, INC.
    Product Code
    LWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SCANNER IS USED TO COUNT SOFT OR COUNT ITEMS USING A BAR CODE. THE STAFF CLOSED THE REPORT AND RE-OPENED AS APPROPRIATE. AT THE END OF THE PROCEDURE WHEN THE STAFF WANTED TO DOWNLOAD THE REPORT THEY PLACED THE SCANNER INTO THE CHARGING BASE AND IT WAS NOTED THE REPORT WOULD NOT DOWNLOAD. THE USUAL PROCEDURE IS TO SHUT DOWN THE PC AND REBOOT WHICH WAS DONE WITHOUT SUCCESS. STAFF USED ANOTHER CHARGING BASE WITHOUT A SUCCESSFUL DOWNLOAD. TROUBLESHOOTING PER COMPANY PROCEDURE WAS DONE THAT INCLUDED A WARM RE-BOOT THEN COLD RE-BOOT WITHOUT SUCCESS. COMPANY CONTACTED WHO PROVIDED REPORT. THE SCANNER WHICH WAS DETERMINED TO HAVE MALFUNCTIONED WAS RETURNED TO COMPANY. COMPANY SUSPECTS THE SCANNER MAY HAVE MALFUNCTIONED. SURGICOUNT MEDICAL HAS BEEN VERY RESPONSIVE TO OUR NEEDS AND COOPERATIVE IN QUICKLY RESOLVING THESE DOWNLOADING ISSUES. NO HARM TO ANY PATIENT- BUT POTENTIAL FOR LOSS OF DATA IN THE MEDICAL RECORD.======================MANUFACTURER RESPONSE FOR SURGICAL BAR CODE SCANNER, SURGICOUNTER BY HONEYWELL (PER SITE REPORTER).======================THEY ARE IN THE PROCESS OF REPLACING ALL THE CHARGING BASES FOR THE SCANNERS. ALSO THEY WILL EXAMINE ALL SCANNERS AND REPLACE/REPAIR AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488247 SURGICOUNTER COUNTER, SPONGE, SURGICAL LWH SURGICOUNT MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *