BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT DOWNLOADER, NETWORK

    MDR report key: 6875351 · Received September 19, 2017

    Report

    Report Number
    2245578-2017-00299
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    August 31, 2017
    Report Date
    December 11, 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
    CA, 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 12/01/2017. THE CUSTOMER REPORTED THAT NETWORK DOWNLOADER RECHARGER (DRN) S/N (B)(4) WAS GENERATING VISIBLE SMOKE. THE CUSTOMER'S COMPLAINT WAS NOT REPRODUCED AND NO CAUSE OR POTENTIAL CAUSE WAS FOUND. THE DRN WAS FOUND TO BE OPERATING AS PER SPECIFICATION REQUIREMENTS WHEN TESTED WITH RECHARGEABLE POWER PACKS AND AN ENGINEERING ANALYZER. UPON UNCASING (B)(4) AND EXAMINING THE FAST CHARGE PCBA, MAIN BOARD, LANTRONIC COBOX, ALTERNATE CHARGE PCBA, AND THE IR PCBA UNDER A MICROSCOPE AND TAKING RESISTANCE READINGS AS REQUIRED, NO DAMAGED/BURNT COMPONENTS WERE OBSERVED AND NO BURNT ODOR WAS NOTED. A ROCKETWARE SEARCH SPANNING TWELVE MONTHS REVEALED NO RELATED INCIDENTS WHERE A DOWNLOADER REPORTEDLY EMITTED SMOKE AT THE CUSTOMER SITE BUT WAS NOT REPRODUCED AND NO CAUSE OR POTENTIAL CAUSE WAS FOUND. 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 DOWNLOADED RECHARGER (B)(4). THE CUSTOMER UNPLUGGED THE DEVICE AND REMOVED IT FROM ITS LOCATION. THE PRODUCT WAS REPLACED AT NO CHARGE AND WILL BE RETURNED 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
    657980 I-STAT DOWNLOADER, NETWORK DOWNLOADER, NETWORK RHA ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1