BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BATTERY MODULE G

    MDR report key: 2843693 · Received October 26, 2012

    Report

    Report Number
    1314492-2012-00373
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION AND FOUND THAT FLUID INTRUSION OCCURRED. THE FLUID CAUSED A SHORT ON THE VEATT WHICH CAUSED THE PRINTED CIRCUIT BOARD TO OVERHEAT. FURTHER ENGINEERING INVESTIGATION FOUND THAT THE FLUID WAS ABLE TO ENTER THE BATTERY MODULE DUE TO A LACK OF GREASE AT THE TOP OF THE CASE. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID INTRUSION OCCURRED ON A BATTERY MODULE. THE CUSTOMER STATED THAT SODA WAS SPILLED ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRELESS BATTERY MODULE G WIRELESS MODULE FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1