BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN PROSPEC SYSTEM

    MDR report key: 14523926 · Received May 27, 2022

    Report

    Report Number
    9610806-2022-00039
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 27, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    UDI-DI
    00630414002736
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE SITE AND CONFIRMED THAT THE BN PROSPEC POWER SUPPLY HAD FAILED. THE CSE REPLACED THE POWER SUPPLY, AFTER WHICH THE SYSTEM RETURNED TO NORMAL OPERATION. THE CAUSE OF THE EVENT WAS THE POWER SUPPLY FAILURE. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    AFTER THE CUSTOMER TURNED ON THEIR BN PROSPEC SYSTEM, THE SYSTEM MADE A BANGING NOISE, AFTER WHICH SMOKE WAS EMITTED FROM THE SYSTEM AND VAPOR FILLED THE ROOM. THE SYSTEM WAS POWERED DOWN AND WAS TAKEN OUT OF OPERATION. THE SYSTEM WAS DOWN FOR ONE DAY AND THERE WAS A DELAY IN PATIENT TESTING OF ONE DAY. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664293 BN PROSPEC SYSTEM BN PROSPEC SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN PROSPEC SYSTEM 00630414002736

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown