BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART BATTERY

    MDR report key: 1879524 · Received August 5, 2010

    Report

    Report Number
    1879524
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 4, 2010
    Manufacturer
    LIFESYNC CORPORATION
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LOW BATTERY AUDIBLE ALARM ACTIVATED 10 HOURS AFTER BATTERY EXCHANGE. THE RN SAW 2 OF 5 POWER BARS. THE BATTERY WAS REPLACED. THE PATIENT'S CARDIAC RHYTHM WAS NOT LOST. ROUTINELY, THIS FACILITY EXCHANGES THE BATTERIES EVERY 12 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART BATTERY KIT, BATTERY, WIRELESS PHYSIOLOGICAL MONITOR DRG LIFESYNC CORPORATION LS-121 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *