BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT DOWNLOADER, NETWORK

    MDR report key: 4202781 · Received October 27, 2014

    Report

    Report Number
    2245578-2014-00077
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JQP
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 01/12/2015. FAILURE RESULTED FROM AN UNKNOWN LIQUID INGRESS CAUSING A COMPONENT TO SHORT CIRCUIT.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO STATED THAT SMOKE WAS COMING FROM DOWNLOADER-PRINTER CORD/PORT OF DOWNLOADER SERIAL NUMBER (B)(4). THE PRODUCT WAS REPLACED AT NO CHARGE PER SERVICE AGREEMENT AND RETURNING FOR FURTHER INVESTIGATION. THERE WERE NO INJURIES REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    NA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683898 I-STAT DOWNLOADER, NETWORK DOWNLOADER, NETWORK JQP ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1