BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON SIGNATURE ELITE

    MDR report key: 7266551 · Received February 12, 2018

    Report

    Report Number
    MW5075205
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    February 7, 2018
    Report Date
    February 9, 2018
    Manufacturer
    ACCRIVA DIAGNOSTIC INC., DBA INC, DBA ACCUMETRICS
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ACT MACHINE FROM (B)(6) 2018 HAD ERROR AND WOULD NOT PERFORM ANY FUNCTIONS. LAB WAS NOTIFIED AND ACT MACHINE WAS EXCHANGED. THIS AM ACT MACHINE WOULD NOT PERFORM ELECTRIC QC AND LOCKED OUT. LAB WAS NOTIFIED AND ACT WAS EXCHANGED. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106444 HEMOCHRON SIGNATURE ELITE ACT MACHINE JPA ACCRIVA DIAGNOSTIC INC., DBA INC, DBA ACCUMETRICS

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO