BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11121831 · Received January 6, 2021

    Report

    Report Number
    2016493-2021-01296
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Report Date
    November 22, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT

    Description of Event or Problem · 1

    CASE #: 00911033 CASE SUBJECT: NPI 8015 ERROR 800.8000 ACCOUNT NAME: PROVIDENCE ST VINCENT MEDICAL CENTER ACCOUNT #: 1781800 ASSET NAME: 8015LS PCU DOM V9.19.1.2 A/B/G ASSET LOCATION: CONTACT: PAUL KARAYKOZA CONTACT EMAIL: [email protected] CONTACT PHONE: 503-216-2985 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: PAUL KARAYKOZA / BIOMED NEED ASSISTANCE ON 8015 SN (B)(4) HAVING AN ERROR 800.8000 FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8015 FAILURE MODE: SEE CASE NOTES CASE RESOLUTION: I ASSISTED PAUL KARAYKOZA / BIOMED NEED ON 8015 SN (B)(4) HAVING AN ERROR 800.8000, RESOLUTION IS TO RE-FLASHED 8015 DEVICE IF CONTINUE TO SHOW UP THE ERROR 800.8000 MORE LIKELY THE LOGIC BOARD MUGHT BE FAULTY AND NEED TO REPLACED LOGIC BOARD. IF NEED MORE ASSISTANCE, BIOMED WILL CALL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20667 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1