BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT DOWNLOADER, NETWORK

    MDR report key: 6926795 · Received October 7, 2017

    Report

    Report Number
    2245578-2017-00548
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 26, 2017
    Report Date
    December 19, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    RHA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 12/18/2017. THE CUSTOMER REPORTED THAT NETWORK DOWNLOADER (DRN) S/N (B)(4) BEGAN TO EMIT SMOKE WHEN AN ANALYZER WAS DOCKED. DRN S/N (B)(4) WAS RETURNED AS "TRANSFER" TO FLEX. BASED ON MATERIAL DESTRUCT ORDER MDO # OCT 2017-02, DRN S/N (B)(4) WAS SCRAPPED WITHOUT ANY INSPECTION OR EVALUATION PERFORMED. A ROCKETWARE SEARCH SPANNING SIX MONTHS REVEALED ONE POTENTIALLY RELATED INCIDENT AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED VISUAL SMOKE COMING FROM NETWORK DOWNLOADER (B)(4). THE DEVICE WAS TAKEN OUT OF SERVICE, REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707345 I-STAT DOWNLOADER, NETWORK DOWNLOADER, NETWORK RHA ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1