BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11509567 · Received March 17, 2021

    Report

    Report Number
    2016493-2021-30251
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Report Date
    February 18, 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
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H10 AND H6, ANNEX G.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 15894643 (36) 8015 PCU KEYPAD WERE REPLACED BECAUSE OF DEFECTIVE KEYPAD. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    "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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(4) (36) 8015 PCU KEYPAD WERE REPLACED BECAUSE OF DEFECTIVE KEYPAD. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405475 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1