BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM WIRELESS BATTERY MODULE G

    MDR report key: 3240843 · Received July 17, 2013

    Report

    Report Number
    1314492-2013-01347
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE WIRELESS BATTERY MODULE WAS RETURNED AND EVALUATED BY BAXTER. EVAL RECEIVED THE MODULE INOPERABLE WITH A "CHECK BATTERY" CONDITION. THE MODULE FAILED PERFORMANCE AND INSPECTION TESTING DUE TO A FAILURE ON THE RADIO PCB, RENDERING THE MODULE NOT REPAIRABLE. THE MODULE WAS DETERMINED TO NOT BE OPERATING WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. THE WIRELESS BATTERY MODULE WAS RETIRED FROM SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WIRELESS BATTERY MODULE WILL NOT CONNECT TO THE FACILITY'S SERVER. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332473 SPECTRUM WIRELESS BATTERY MODULE G WIRELESS BATTERY MODULE FRN BAXTER HEALTHCARE CORP 35162

    Patients

    Seq Age Sex Outcome Treatment
    1