BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT DOWNLOADER RECHARGER, NETWORK

    MDR report key: 18696282 · Received February 13, 2024

    Report

    Report Number
    2245578-2024-00020
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 23, 2024
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: (B)(4). THE INVESTIGATION WAS COMPLETED ON 22-APR-2024. THE CUSTOMER REPORTED THAT NETWORK DOWNLOADER (DRN) S/N (B)(6) WAS FUMING, AND THE POWER CORDS BECAME HOT WHEN PLUGGED INTO THE AC POWER SUPPLY. THE CONCLUSION OF THE INVESTIGATION IS THAT THE CUSTOMER'S COMPLAINT WAS CONFIRMED. ALTHOUGH THE SMOKE AND THE HOT TO TOUCH CONDITION OF THE POWER CABLE OBSERVED BY THE CUSTOMER WERE NOT REPRODUCED, THE CAUSE OF THE COMPLAINT WAS DETERMINED TO BE A DAMAGED POWER SUPPLY ADAPTER AND POWER CABLE. THE DAMAGE WAS OBSERVED TO BE WEAR AND TEAR: CORROSION (POTENTIALLY FROM SPILLED LIQUID) ON THE POWER SUPPLY ADAPTER BODY, A BROKEN POWER SUPPLY ADAPTER SOCKET PIN, AND DAMAGED INSULATION WITH EXPOSED COPPER WIRE ON THE POWER CABLE. AS DRN S/N (B)(6), WITH THE POWER CABLE AND THE POWER SUPPLY ADAPTER, WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2010 AND WAS IN THE FIELD FOR OVER 13 YEARS PRIOR TO THE CURRENT RETURN, THE DAMAGE OCCURRED OUTSIDE OF APOC CONTROL. A ROCKETWARE SEARCH SPANNING THREE MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: 944409. CORRECTION FILED TO CHANGE SECTION D2B FROM RHA: IR DATA TRANSMIT/CONTROL, TO JQP: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE AS SUGGESTED BY FDA.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    ON 29-JAN-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT DRN-48026 STARTED FUMING AND POWER CORDS BECAME HOT WHEN PLUGGED INTO AC POWER SUPPLY. CUSTOMER ALSO STATED THAT THE AC POWER ADAPTER MODEL #LFZVC36FS12AR SHOWS SPOTTING ON THE OUTSIDE OF CASE. THE PRODUCT IS BEING REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. CUSTOMER WILL RETURN DRN-48026 WITH AC POWER SUPPLY AND POWER CORD BACK TO APOC FOR INVESTIGATION. CUSTOMER REPORTS NO INJURIES OCCURRED FROM THE REPORTED INCIDENT. 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
    166368 I-STAT DOWNLOADER RECHARGER, NETWORK DOWNLOADER RECHARGER, JQP ABBOTT POINT OF CARE NA NA
    765989 I-STAT DOWNLOADER RECHARGER, NETWORK DOWNLOADER RECHARGER, JQP ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown