BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT DOWNLOADER RECHARGER, NETWORK

    MDR report key: 1991546 · Received January 28, 2011

    Report

    Report Number
    2245578-2011-00008
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING NETWORK DOWNLOADER (B)(4) (CAT 514001). THE POWER ADAPTER (PN-013519-01 01) WAS NOT WORKING AND IT WAS WARM TO TOUCH. THE NETWORK DOWNLOADER (B)(4) PERFORMED AS INTENDED WITH A REPLACEMENT POWER ADAPTER. BASED ON THE INFORMATION AT THE TIME, THERE WAS NO INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT DOWNLOADER RECHARGER, NETWORK DOWNLOADER RECHARGER, NETWORK JQP ABBOTT POINT OF CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1