BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOS-5

    MDR report key: 20695098 · Received November 15, 2024

    Report

    Report Number
    1000391282-2024-00003
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 25, 2024
    Report Date
    December 20, 2024
    Manufacturer
    MILESTONE SRL
    Product Code
    IEO
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT IN SECTION H6 WE MARKED "D4315 CAUSE NOT ESTABLISHED" AS WE HAD ONLY PHOTOS OF THE COMPONENTS AND IT WAS NOT POSSIBLE ESTABLISH THE CAUSE(S) OF THE DEVICE FAILURE. SINCE THEN, WE RECEIVED THE PCB (PRINTED CIRCUIT BOARD) FROM THE USER FACILITY AND INVESTIGATED THE COMPONENTS INVOLVED IN THE MALFUNCTION. ANALYSIS OF THE PCB SHOWED THAT THE TRIAC (BIDIRECTIONAL THREE-ELECTRODE AC SWITCH AND THE RELAY, INDEPENDENT SECONDARY POWER SUPPLY) WERE BOTH DAMAGED. THE DAMAGE CAUSED A SHORT CIRCUIT, WHICH MEANT THAT NO TEMPERATURE REGULATION WAS POSSIBLE. THIS RESULTED IN HEAT CONTINUING TO BE APPLIED TO THE REAGENT, EVEN AFTER ALL THE ALCOHOL WAS EVAPORATED. THE HEATING WAS INTERRUPTED WHEN THE TWO MAIN FUSES ON THE POWER LINE WERE BLOWN DUE TO THE EXCESSIVE CURRENT REQUIRED. AT NO TIME WAS THERE A RISK OF INJURY TO A PERSON OR ANY RISK OF EXPLOSION OR FIRE BECAUSE THE AUTOIGNITION TEMPERATURE OF THE REAGENTS IS HIGHER THAN THEIR BOILING POINTS AND THE VAPORS CREATED DURING THE BOILING ARE EXTRACTED FROM THE HISTOMODULE DIRECTLY TO THE FACILITY'S VAPOR EXTRACTION SYSTEM. ADDITIONALLY, THE DEVICE IS MADE FROM NON-FLAMMABLE, NON-IGNITABLE MATERIALS. ALTHOUGH IT HAS NOT BEEN CONFIRMED, IT IS HIGHLY LIKELY THAT AN EXTERNAL VOLTAGE SPIKE AT THE USER FACILITY OCCURRED AND DAMAGED THE TWO COMPONENTS (TRIAC AND RELAY) AT THE SAME TIME. TO PREVENT ANOTHER MALFUNCTION, THE USER FACILITY HAS BEEN ADVISED TO INSTALL A POWER LINE CONDITIONER TO HELP MAINTAIN A STABLE AND CONSISTENT VOLTAGE LEVEL AT THE FACILITY.

    Description of Event or Problem · 0

    DURING THE PROCESSING OF SPECIMENT IN THE ISOPROPANOL STEP THE SAMPLES WERE DAMAGED. THERE WAS NO ADVERSE OUTCOME IN A PATIENT, USER, OR OPERATOR.

    Description of Event or Problem · 0

    DURING THE PROCESSING OF SPECIMENT IN THE ISOPROPANOL STEP THE SAMPLES WERE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334515 HISTOS-5 PROCESSOR, TISSUE, AUTOMATED IEO MILESTONE SRL HISTOS-5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown