BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS BATTERY MODULE G

    MDR report key: 2911338 · Received December 11, 2012

    Report

    Report Number
    1314492-2012-00499
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, THE DATE OF EVENT IS UNK. MANUFACTURER REPORT NO. 1314492-2012-00498 IS RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFUSION IN THE EXTENDED CARE UNIT, A STATIC DISCHARGE FROM THE PT'S BLANKET CAUSED THE PUMP TO SHUTDOWN WITHOUT USER INPUT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). THE CUSTOMER STATED THAT THE PUMP COULD NOT BE POWERED ON AGAIN, AND WAS REPLACED. THE CUSTOMER ALSO STATED THAT THERE WAS NO PT INJURY. WHEN THE DEVICE WAS TESTED AFTER THE REPORTED EVENT, IT WAS OBSERVED THAT THE BATTERY HAD NO CHARGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1