BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3053569 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05173
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    November 19, 2012
    Report Date
    March 26, 2013
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    KRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PROGRAMMER WAS PERFORMED. THERE WAS NO OUTPUT TO THE SCREEN DUE TO THE UPPER HALF OF THE PROGRAMMER INVERTER BEING DEFECTIVE, CAUSING A BLACK SCREEN UPON BOOT UP.THE DEFECTIVE INVERTER HAD MELTED THE INVERTER COVER. THE INVERTER WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A HEALTH CARE PROFESSIONAL (HCP) THAT THE PROGRAMMER SCREEN REMAINED BLACK. REBOOTING SEVERAL TIMES DID NOT RESOLVE THE ISSUE. PROGRAMMER WAS RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155627 ZOOM KRG EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1