BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BATTERY MODULE B

    MDR report key: 3780230 · Received January 3, 2014

    Report

    Report Number
    1314492-2014-00495
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Date of Event
    December 1, 2013
    Report Date
    December 6, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM. THE INVESTIGATION REVEALED CORROSION ON THE WIRELESS MODULE FLEX AND RADIO PRINTED CIRCUIT BOARD, RENDERING THE UNIT IRREPARABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WIRELESS BATTERY MODULE SUFFERS FROM FLUID INTRUSION. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5029 WIRELESS BATTERY MODULE B WIRELESS BATTERY FRN BAXTER HEALTHCARE CORP. 35083

    Patients

    Seq Age Sex Outcome Treatment
    1