BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 3894369 · Received April 23, 2014

    Report

    Report Number
    9615050-2014-02918
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    Z-0624-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS MISSING AND THE DOOR ROLLER PIN WAS BROKEN. FURTHER TESTING FOUND THE DEVICE HAD UNRESTRICTED FLOW WHEN THE DOOR WAS OPENED. THIS WAS DUE TO THE MISSING DEVICE DOOR ROLLER AND BROKEN DOOR ROLLER PIN. THE MISSING DEVICE DOOR ROLLER AND BROKEN DOOR ROLLER PIN PREVENTED PROPER ACTUATION OF THE REGULATOR CLOSER ON THE DEVICE MECHANISM CAUSING UNRESTRICTED FLOW WHEN THE DOOR WAS OPENED. THE CUSTOMER CONTACT'S REPORTED BROKEN CE MODULE ANTENNA HOUSING WAS DUPLICATED DURING TESTING. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE CE MODULE ANTENNA HOUSING WAS SMASHED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS MISSING AND THE DOOR ROLLER PIN WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245238 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 #20791,| (B)(4)