BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BATTERY MODULE G

    MDR report key: 2896729 · Received November 21, 2012

    Report

    Report Number
    1314492-2012-00442
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. DURING EVAL, EVIDENCE OF OVERHEATING ON THE WIRELESS MODULE FLEX PRINTED CIRCUIT BOARD WAS OBSERVED. SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BATTERY MODULE WAS OBSERVED TO BE BURNED AND THE DEVICE WOULD NOT CHARGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1