BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER EDITI

    MDR report key: 4110053 · Received September 11, 2014

    Report

    Report Number
    9615050-2014-05167
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE FAILED THE DISTAL OCCLUSION TEST. THE DEVICE PASSED THE DISTAL OCCLUSION TEST SO THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, FURTHER DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS FOUND THE DEVICE REGULATOR CLOSER WAS UNSEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562407 PLUM A+ DRIVER EDITI 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA