BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3003135857-2008-00045

    MDR report key: 1180723 · Received July 21, 2008

    Report

    Report Number
    3003135857-2008-00045
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Product Code
    CBK
    PMA / PMN Number
    K992133
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT IN RESPONSE TO THIS ISSUE, AN IMPORTANT MEDICAL DEVICE CORRECTION LETTER WAS ISSUED ON 9/14/07 AS A SHORT TERM FIX. THE FIRM HAS SUBMITTED A LONG TERM CORRECTION AS A SUPPLEMENT TO ITS 510K WHICH IS PENDING REVIEW BY THE FDA. ACCORDING TO THE MFR'S OPERATING MANUAL OF THE HT50 MODEL, THE INTERNAL BATTERY SHOULD BE REPLACED YEARLY OR WHEN THE BATTERY NO LONGER MEETS THE NEEDS OF THE USER. FROM THE SVC RECORD OF THIS UNIT, THE BATTERY WAS LAST REPLACED MORE THAN ONE YEAR AGO. DEVICE FAILURE WAS MOST LIKELY RELATED TO USER MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBK

    Patients

    Seq Age Sex Outcome Treatment
    1