BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 11373688 · Received February 24, 2021

    Report

    Report Number
    2016493-2021-28075
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Report Date
    February 8, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE OF UNRESPONSIVE (SHORTED) KEYPAD IS CONFIRMED BASED ON THE FIELD ACTION. NO FURTHER COMPLAINT INVESTIGATION IS NECESSARY AS CAPA PR 1120033 WAS OPENED TO ADDRESS THIS ISSUE. THE DEVICE IS USED FOR TREATMENT PURPOSES. CUSTOMERS RECEIVED NOTIFICATION OF THE FIELD ACTION. DEVICE REPAIR OR RETURNS ARE HANDLED WITHIN THE SCOPE OF THE FIELD ACTION. NO FURTHER INFORMATION WILL BE PROVIDED BY THE CUSTOMERS DUE TO THE FIELD ACTION H3 OTHER TEXT : DEVICE HAS BEEN SERVICED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD ONE (1) 8015 THAT WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD ONE (1) 8015 THAT WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270374 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1