BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BATTERY MODULE G

    MDR report key: 3101837 · Received May 1, 2013

    Report

    Report Number
    1314492-2013-00472
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 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 BATTERY MODULE WAS REC'D INOPERABLE BY BAXTER. THE DEVICE ALARMED FOR "CHECK BATTERY" DUE TO CORROSION ON THE WIRELESS MODULE FLEX AND RADIO PCB AS A RESULT OF FLUID INTRUSION. THIS CAUSED THE COMPONENTS TO FAIL, RENDERING THE UNIT UN-REPAIRABLE. THE UN-REPAIRABLE WIRELESS MODULE WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WIRELESS MODULE WOULD NOT CONNECT TO THE CUSTOMER'S WIRELESS NETWORK. IT WAS ALSO REPORTED THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190798 WIRELESS BATTERY MODULE G WIRELESS BATTERY MODULE FRN BAXTER HEALTHCARE CORPORATION 35162

    Patients

    Seq Age Sex Outcome Treatment
    1