BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 2170001 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10184
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    January 11, 2012
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THIS PRODUCT WAS ANALYZED. RADIOFREQUENCY INTERROGATION WAS PERFOMRED ALONG WITH THRESHOLD TESTING WITHOUT ELECTROGRAM DROP OUT. IT WAS CONCLUDED THAT THIS PRODUCT WAS OPERATING WITHIN SPECIFICATIONS AND THE CLINICAL OBSERVATION WAS UNABLE TO BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT AN ACCOUNT HAS HAD HISTORY OF ELECTROMAGNETIC AND RADIOFREQUENCY ISSUES IN THE PAST. THERE HAVE BEEN REPORTED OF WIRELESS TELEMETRY DROPOUT DURING THRESHOLDS TESTS THAT LEADS TO THE PATIENTS GOING ASYSTOLE FOR SEVERAL SECONDS. NO DIRECT PATIENT SERIOUS INJURIES HAVE BEEN REPORTED. TECHNICAL SERVICES DISCUSSED 'CANCEL TELEMETRY' POPUP AND THAT THEY MAY NEED TO CONSIDER USING WAND ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1