BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BATTERY MODULE G

    MDR report key: 3934119 · Received February 1, 2014

    Report

    Report Number
    1314492-2014-07300
    Event Type
    Malfunction
    Date Received
    February 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 FLUID INTRUSION. INVESTIGATION REVEALED CORROSION ON THE WIRELESS MODULE FLEX AND RADIO PRINTED CIRCUIT BOARD AS A RESULT OF FLUID INTRUSION; RENDERED THE UNIT IRREPARABLE. THE DEVICE HAS BEEN RETIRED FROM SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WIRELESS BATTERY MODULE EXPERIENCED FLUID INTRUSION. THERE WAS NO REPORTED PATIENT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69374 WIRELESS BATTERY MODULE G WIRELESS BATTERY FRN BAXTER HEALTHCARE CORPORATION 35162

    Patients

    Seq Age Sex Outcome Treatment
    1