BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM WIRELESS BATTERY MODULE G

    MDR report key: 3221962 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01023
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 7, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. THE DEVICE FAILED TO PASS TESTING DUE TO A FAILURE ON THE RADIO PRINTED CIRCUIT BOARD. THE DEVICE COULD NOT BE REPAIRED AND WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WOULD NOT CONNECT TO THE CUSTOMER'S WIRELESS NETWORK. IT WAS ALSO REPORTED THAT THIS WAS FOUND DURING TESTING, AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307601 SPECTRUM WIRELESS BATTERY MODULE G WIRELESS BATTERY MODULE FRN BAXTER HEALTHCARE CORP 35162

    Patients

    Seq Age Sex Outcome Treatment
    1