BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BATTERY MODULE G

    MDR report key: 2944300 · Received January 11, 2013

    Report

    Report Number
    1314492-2013-00023
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 13, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION AND IT WAS OBSERVED THAT THE PUMP LOST POWER WHEN THE DEVICE'S MOTOR ENGAGED. THIS WAS FOUND TO BE CAUSED BY A FAILED BATTERY CELL OF THE WIRELESS BATTERY MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP POWERS OFF WHEN A SET IS INSERTED. THE CUSTOMER STATED THAT THE BATTERY IS FULLY CHARGED. THE CUSTOMER ALSO STATED THAT THE ISSUE WAS DISCOVERED DURING PREVENTIVE MAINTENANCE AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19210 WIRELESS BATTERY MODULE G WIRELESS BATTERY MODULE FRN BAXTER HEALTHCARE CORP. 35162

    Patients

    Seq Age Sex Outcome Treatment
    1