BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM WIRELESS BATTERY MODULE G

    MDR report key: 3221986 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01027
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. THE EVALUATION CONFIRMED THAT THE DEVICE WOULD NOT CONNECT TO A WIRELESS NETWORK CAUSED BY CORROSION ON THE WIRELESS MODULE FLEX AND RADIO PRINTED CIRCUIT BOARD. THE CORROSION WAS DETERMINED TO BE CAUSED BY FLUID INTRUSION. THE DEVICE WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP COULD NOT CONNECT TO THE CUSTOMER'S WIRELESS NETWORK. THE CUSTOMER STATED THAT THE PUMP WILL POWER ON, THEN RESTART WITHOUT USER INPUT. THERE WAS NO PT INJURY, AND NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307606 SPECTRUM WIRELESS BATTERY MODULE G WIRELESS BATTERY MODULE FRN BAXTER HEALTHCARE CORPORATION 35162

    Patients

    Seq Age Sex Outcome Treatment
    1