BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BATTERY MODULE B

    MDR report key: 3922330 · Received February 5, 2014

    Report

    Report Number
    1314492-2014-06258
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM. EVIDENCE OF FLUID INTRUSION WAS FOUND ON THE WIRELESS BATTERY MODULE FLEX ASSEMBLY, WHICH WAS REPLACED. UPON FURTHER INVESTIGATION, THE FRONT CASE BOSS AND REAR CASE WERE FOUND TO BE DAMAGED. THE WIRELESS BATTERY MODULE FLEX ASSEMBLY, FRONT CASE, AND REAR CASE WERE REPLACED, WITH CORRESPONDING PARTS AND LABELS, WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WIRELESS BATTERY MODULE HAD WATER DAMAGE. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74675 WIRELESS BATTERY MODULE B WIRELESS BATTERY FRN BAXTER HEALTHCARE CORPORATION 35083

    Patients

    Seq Age Sex Outcome Treatment
    1