BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 10053644 · Received May 13, 2020

    Report

    Report Number
    2016493-2020-00890
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Report Date
    August 29, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K950419
    Removal / Correction Number
    Z-2076-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORT OF A PCU U21 PWR SUPPLY BD RECALL 2012 WAS ADDRESSED DURING THE SERVICE REPAIR PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE CUSTOMER REPORTED EVENT WAS CONFIRMED DURING THE SERVICE INVESTIGATION PROCESS. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORT OF A PCU U21 PWR SUPPLY BD RECALL 2012 WAS ADDRESSED DURING THE SERVICE REPAIR PROCESS. THE PROXIMATE CAUSE OF THE PWR SUPPLY BD RECALL WAS DETERMINED BY SERVICE TO BE DUE TO A FAULTY U21 IC ON THE PCU POWER SUPPLY BOARD. THE PROXIMATE CAUSE OF THE BATTERY PACK ISSUE WAS REPORTED BY SERVICE TO BE DUE TO WEAR. THE PROXIMATE CAUSE OF THE KEYPAD ASSEMBLY AND REAR CASE WAS REPORTED BY SERVICE TO BE DUE TO CUSTOMER DAMAGE.

    Description of Event or Problem · 0

    THE DEVICE WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORT OF A PCU U21 PWR SUPPLY BD RECALL 2012 WAS ADDRESSED DURING THE SERVICE REPAIR PROCESS. THE PROXIMATE CAUSE OF THE PWR SUPPLY BD RECALL WAS DETERMINED BY SERVICE TO BE DUE TO A FAULTY U21 IC ON THE PCU POWER SUPPLY BOARD. THE PROXIMATE CAUSE OF THE BATTERY PACK ISSUE WAS REPORTED BY SERVICE TO BE DUE TO WEAR. THE PROXIMATE CAUSE OF THE KEYPAD ASSEMBLY AND REAR CASE WAS REPORTED BY SERVICE TO BE DUE TO CUSTOMER DAMAGE.

    Description of Event or Problem · 1

    THE DEVICE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514272 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown