BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11008390 · Received December 15, 2020

    Report

    Report Number
    2016493-2020-68337
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Report Date
    May 7, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS NOT PERFORMED BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FOR THE SUSPECT DEVICE. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(6) HAD ERROR 133.6090 ON PCU8015. BATTERY WAS CHARGED AND HE HAS REPLACED MAIN SPEAKER. BUT THE ERROR STILL EXIST. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT. FAILURE PROBLEM TYPE: 8015. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: I RECOMMENDED (B)(6) TO REPLACE SIO BOARD ASSY. IF SIO BOARD DID NOT RESOLVE THE ISSUE, (B)(6) WILL REPLACE LOGIC BOARD. IF HE STILL HAVE ANY ISSUE, HE WILL CALL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475822 8015 ALARIS SYSTEM PC UNIT PUMP,INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1