BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10919093 · Received November 30, 2020

    Report

    Report Number
    2016493-2020-52178
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Report Date
    December 14, 2018
    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

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. 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 RETURNED FOR SERVICING WHICH 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

    WON'T TURN ON / OFF- 12/14/2018 11:43:44 RFC_REPAIRS (RFC_REPAIRS) OUT OF BOX FAILURE: FAILED INCOMING INSPECTION DUE TO WILL NOT POWER ON EVEN AFTER 18+ HOUR CHARGE. AC POWER INDICATOR IS LITE WHEN PLUGGED IN. ON 01/04/2019 12:49:07 (B)(4). CAD HAS REVIEWED THIS ESCALATED ISSUE AND DETERMINED THAT THE PCU NEEDS TO BE SENT TO THE OPERATIONS ENGINEEERING LAB FOR INVESTIGATION GIVEN THAT IT IS AN OUT OF BOX FAILURE. 01/15/2019 08:38:02 (B)(4). CONCLUSION: DEFECTIVE CAPACITORS (BURNT) C65, C102 , AN C153 (CAP CER X7R 0.47UF 100V 10% 1210), PART NUMBER 823935-474 ON THE INPUT LINE OF A 3.3 VOLTS REGULATOR ARE THE MAIN CAUSE OF PCU FAILED TO POWER ON. REWORK: RECOMMEND REPLACING POWER SUPPLY BOARD PART NUMBER: TC10006929. THE DEFECTIVE POWER SUPPLY WILL BE SENT BACK TO SUPPLY FOR FURTHER FAILURE ANALYSIS. DISPOSITION ROUTE TO SERVICE FOR NORMAL PROCESS. ON 01/30/2019 08:45:18 (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383332 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1