BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 12081907 · Received June 29, 2021

    Report

    Report Number
    2016493-2021-508748
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Report Date
    November 20, 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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S EXPERIENCE OF KEYPAD FAILURES WAS CONFIRMED AND REPLICATED DURING TESTING ON 2 OF THE 4 PCU DEVICES RETURNED FOR THIS INVESTIGATION. ¿ FUNCTIONAL TESTING CONSISTING OF ASM KEYPAD TESTING WAS PERFORMED ON THE SOURCE PCUS WHICH IDENTIFIED 2 OF THE 4 RETURNED PCU DEVICES NOT OPERATING AS EXPECTED. (S/N: (B)(6)). ¿ AN INTERNAL INSPECTION CONFIRMED OPEN TRACES ON THE PCU(S) (S/N: (B)(6)) KEYPAD FLEX CABLES. ¿ THE CUSTOMER¿S FRONT COVER ON THE FOLLOWING PCUS WERE BOTH REPLACED WITH A KNOWN GOOD PART AND THE ASM KEYPAD TEST WAS RE-RUN. TEST RESULTS CONFIRMED THE KEYPADS NOW FUNCTIONED AS EXPECTED. O PCU ¿ S/N: (B)(6)- (PRINTEC KEYPAD P/N: TC10010217 REV.02 ¿ LOT: 060660 S/N (B)(6) DATE CODE: (B)(6) 2018). O PCU ¿ S/N: (B)(6)- (PRINTEC KEYPAD P/N: TC10010217 REV.02 ¿ LOT: 060660 S/N (B)(6) DATE CODE: (B)(6) 2018). ¿ THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE ARE MULTIPLE 8015 DEVICES THAT HAVE KEYPAD FAILURES WHICH INCLUDE FLUID INGRESS, KEYPADS DELAMINATION AND NON FUNCTIONING KEYPAD BOTTOMS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT WERE FOUND DURING PREVENTATIVE MAINTENANCE. (PM).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S EXPERIENCE OF KEYPAD FAILURES WAS CONFIRMED AND REPLICATED DURING TESTING ON 2 OF THE 4 PCU DEVICES RETURNED FOR THIS INVESTIGATION. FUNCTIONAL TESTING CONSISTING OF ASM KEYPAD TESTING WAS PERFORMED ON THE SOURCE PCUS WHICH IDENTIFIED 2 OF THE 4 RETURNED PCU DEVICES NOT OPERATING AS EXPECTED. (S/N: (B)(4)). AN INTERNAL INSPECTION CONFIRMED OPEN TRACES ON THE PCU(S) (S/N: (B)(4)) KEYPAD FLEX CABLES. THE CUSTOMER¿S FRONT COVER ON THE FOLLOWING PCUS WERE BOTH REPLACED WITH A KNOWN GOOD PART AND THE ASM KEYPAD TEST WAS RE-RUN. TEST RESULTS CONFIRMED THE KEYPADS NOW FUNCTIONED AS EXPECTED. PCU ¿ S/N: (B)(4) - (PRINTEC KEYPAD P/N: TC10010217 REV.02 ¿ LOT: 060660 S/N (B)(4) DATE CODE: 18/02 FEB 2018). PCU ¿ S/N: (B)(4) - (PRINTEC KEYPAD P/N: TC10010217 REV.02 ¿ LOT: 060660 S/N (B)(4) DATE CODE: 18/02 FEB 2018). THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE ARE MULTIPLE 8015 DEVICES THAT HAVE KEYPAD FAILURES WHICH INCLUDE FLUID INGRESS, KEYPADS DELAMINATION AND NON FUNCTIONING KEYPAD BOTTOMS. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT WERE FOUND DURING PREVENTATIVE MAINTENANCE. (PM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980694 8015 ALARIS SYSTEM PC UNIT FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown