BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT DOWNLOADER RECHARGER

    MDR report key: 11448816 · Received March 9, 2021

    Report

    Report Number
    2245578-2021-00021
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    March 2, 2021
    Report Date
    June 2, 2021
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JQP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: 853890 THE INVESTIGATION WAS COMPLETED ON 25-MAY-2021. THE CUSTOMER REPORTED THAT I-STAT1 DOWNLOADER RECHARGER (DRC) (B)(6) HAD "SPARKS" APPEAR NEAR THE CHARGING CONTACTS WHEN DOCKING I-STAT1 ANALYZER (B)(6) ON THE DRC. THE CUSTOMER FURTHER REPORTED THAT THERE IS A SCORCH MARK RIGHT ABOVE THE CONTACT PINS OF THE DRC AND ON THE RECHARGE CONTACT PADS OF THE ANALYZER. THE CUSTOMER COMPLAINT WAS CONFIRMED UPON VISUAL EXAMINATION OF DRC-74105 AND ANALYZER (B)(6): A SCORCH MARK WAS OBSERVED ABOVE THE CONTACT PINS AND RECHARGE CONTACT PADS, RESPECTIVELY. FUNCTIONAL TESTS TO ENSURE CORRECT CHARGING CAPABILITIES WERE PERFORMED ON THE DRC AND THE ANALYZER, AND IT WAS DETERMINED THAT THE DRC WAS ABLE TO CHARGE THE RETURNED ANALYZER AS EXPECTED. NO HOT TO TOUCH OR WARM CONDITIONS WERE NOTED, AND NO ADDITIONAL SCORCH MARKS WERE OBSERVED ON EITHER THE ANALYZER OR THE DRC. THE DRC AND ANALYZER WERE UNCASED, AND ALL INTERNAL COMPONENTS WERE INSPECTED. NO SIGNS OF CONTAMINATION, DAMAGE, OR BURNT COMPONENTS WERE NOTED. THE RECHARGE CONTACT PADS OF THE ANALYZER DID HAVE SOME CHARRING AND DEBRIS FROM THE "SPARK". CRITICAL COMPONENTS SUCH AS FUSES AND TRANSISTORS, WERE EXAMINED IN DEPTH VIA ENGINEERING ANALYSIS TECHNIQUES, AND ALL COMPONENTS WERE DETERMINED TO BE FUNCTIONING AS PER SPECIFICATION. THE CONCLUSION OF THIS INVESTIGATION IS THAT THE DRC AND THE ANALYZER FUNCTIONED ACCORDING TO SPECIFICATIONS DURING FAILURE ANALYSIS. IT SHOULD BE NOTED THAT THE DRC POWER CABLES/ADAPTERS AND THE I-STAT1 RECHARGEABLE POWER PACK HAVE NOT BEEN RETURNED FOR INVESTIGATION, AND THERE IS INSUFFICIENT EVIDENCE TO RULE OUT THESE ITEMS AS HAVING CONTRIBUTED TO THE COMPLAINT.

    Description of Event or Problem · 0

    NA.

    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)(6) 2021, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REPORTING THAT I-STAT 1 DOWNLOADER RECHARGER DRC-74105 HAD SMALL SPARKS APPEAR NEAR THE CHARGING CONTACTS WHEN DOCKING AN I-STAT1 ANALYZER, SN (B)(4). CUSTOMER STATES THE CORRECT POWER SUPPLY WAS BEING USED. THE PRODUCT WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION ALONG WITH POWER SUPPLY AND ANLYZER THAT WAS DOCKED AT THE TME OF THE EVENT. THERE WERE NO INJURIES REPORTED. PER I-STAT1 SYSTEM MANUAL: ART: 714368-00K, REV. DATE: 02-AUG-12: 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
    346597 I-STAT DOWNLOADER RECHARGER DOWNLOADER/RECHARGER JQP ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1