BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM WIRELESS BATTERY MODULE G

    MDR report key: 3192376 · Received June 18, 2013

    Report

    Report Number
    1314492-2013-00797
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE WIRELESS BATTERY MODULE WAS RETURNED AND EVALUATED BY BAXTER. EVAL WAS ABLE TO REPRODUCE THE REPORTED SYMPTOM. EVAL FOUND THE MODULE TO FAILED PERFORMANCE AND INSPECTION TESTING DUE TO A FAILURE ON THE RADIO PRINTED CIRCUIT BOARD, RENDERING THE MODULE NOT REPAIRABLE. THE MODULE WAS DETERMINED TO NOT BE OPERATING WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOMS. THE MODULE WAS RETIRED FROM SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WIRELESS BATTERY MODULE WOULD NOT CONNECT TO THE FACILITY'S SERVER. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276204 SPECTRUM WIRELESS BATTERY MODULE G WIRELESS BATTERY MODULE FRN BAXTER HEALTHCARE CORPORATION 35162

    Patients

    Seq Age Sex Outcome Treatment
    1