BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 4142933 · Received September 12, 2014

    Report

    Report Number
    9615050-2014-05194
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    January 1, 2013
    Report Date
    December 11, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MECHANISM WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SVC CTR WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE DISPLAYED N251 (VALVE/CLASS TEST FAIL) AT START UP. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SVC CTR, THE DEVICE WAS RECEIVED WITH A MISSING REGULATOR CLOSER, REGULATOR OPENER, AND REGULATOR OPENER SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565306 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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