BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 4142980 · Received September 12, 2014

    Report

    Report Number
    9615050-2014-05205
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    January 10, 2014
    Report Date
    February 13, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON (B)(4) 2014. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE AUDIBLE ALARMS FOR AN "E301 MALFUNCTION" AFTER THE DEVICE POWERS ON. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, WHEN THE DEVICE WAS RECEIVED AT THE SERVICE CENTER CHARRING WAS NOTED ON THE FLAT CABLE AND J10 CONNECTOR ON DRIVER PWA (PRINTED CIRCUIT BOARD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565334 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE, LIST # UNK, SN UNK