BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT DOWNLOADER RECHARGER

    MDR report key: 8522239 · Received April 17, 2019

    Report

    Report Number
    2245578-2019-00106
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    April 4, 2019
    Report Date
    July 1, 2019
    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
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 06/27/2019. THE CUSTOMER REPORTED THAT I-STAT 1 DOWNLOADER RECHARGER (DRC) S/N (B)(4) EMITTED SMOKE AND VISIBLE FIRE WHEN CONNECTED WITH THE POWER SUPPLY CABLE AND ADAPTER SUPPLIED WITH THE DRC. THE SAME POWER CABLE WITH ADAPTER WAS PLUGGED INTO ANOTHER DRC, AND IT WAS WORKING FINE. FAILURE ANALYSIS COULD NOT BE PERFORMED AS DRC S/N (B)(4) AND THE ASSOCIATED CABLE AND POWER SUPPLY HAVE NOT BEEN RETURNED TO FLEX. A ROCKETWARE SEARCH SPANNING SIX MONTHS REVEALED NO SIMILAR INCIDENTS. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(4) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REPORTING THAT DOWNLOADER SN (B)(4) THAT EMITTED SMOKE AND VISIBLE FIRE WHEN CONNECTED TO THE POWER SUPPLY CABLE AND ADAPTER SUPPLIED WITH THE DRC. THE CUSTOMER STATES THAT SMOKE CAME AFTER CONNECTING THE CABLE WITH ADAPTER TO THE POWER-SUPPLY & DRC. THE CABLE WITH ADAPTER WAS THEN REMOVED AND OBSERVED IF IT WAS THE CORRECT CABLE. AS THERE WERE NO DAMAGES SEEN, SAME CABLE WITH ADAPTER WAS PLUGGED INTO A ANOTHER DRC AND THAT WORKED FINE. THE BUSINESS PARTNER RETESTED THE SAME CABLE WITH QUESTIONABLE DRC THAT THREW SMOKE AND THE DRC STARTED A FIRE INTERNALLY AND WAS REMOVED FROM SERVICE. THE PRODUCT WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. THE DRC UNIT WILL BE RETURNED ALONG WITH CABLE & ADAPTER. THERE WERE NO INJURIES REPORTED. PER I-STAT1 SYSTEM MANUAL: ART: 714368-00K, REV. DATE: (B)(4) 2012: THE DOWNLOADER/RECHARGER CAN RECHARGE A RECHARGEABLE BATTERY IN THE ANALYZER. IF THE ANALYZER CONTAINS A RECHARGEABLE BATTERY, THE BATTERY BEGINS RECHARGING AUTOMATICALLY AS SOON AS THE ANALYZER IS PLACED IN THE DOWNLOADER/RECHARGER. THE DOWNLOADER/RECHARGER ALSO HAS A COMPARTMENT FOR RECHARGING A RECHARGEABLE BATTERY OUTSIDE THE ANALYZER. PLACING AN ANALYZER IN A DOWNLOADER/RECHARGER WILL AUTOMATICALLY INITIATE RECHARGING OF THE RECHARGEABLE BATTERY. THE INDICATOR LIGHT ON TOP OF THE DOWNLOADER/RECHARGER WILL BE GREEN (TRICKLE CHARGE), RED (FAST CHARGE), OR BLINKING RED (FAST CHARGE PENDING) WHEN AN ANALYZER WITH A RECHARGEABLE BATTERY IS PLACED IN THE DOWNLOADER/RECHARGER. AS WELL, PLACING A RECHARGEABLE BATTERY INTO THE RECHARGING COMPARTMENT WILL AUTOMATICALLY INITIATE TRICKLE RECHARGING. THE INDICATOR LIGHT NEAR THE RECHARGING COMPARTMENT WILL BE GREEN WHEN A RECHARGEABLE BATTERY IS PLACED IN THE COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316121 I-STAT DOWNLOADER RECHARGER DOWNLOADER/RECHARGER RHA ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1