BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+PMP W/SE MOD

    MDR report key: 3912641 · Received May 14, 2014

    Report

    Report Number
    9615050-2014-03408
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    December 12, 2013
    Report Date
    December 12, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    Removal / Correction Number
    Z-0624-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS NOTED THA THE DEVICE DOOR ROLLER WAS BROKEN. THE CUSTOMER CONTACT'S REPORT OF N251 (VALVE/CASSETTE TEST FAILURE) WAS NOTED IN THE DEVICE HISTORY, BUT NOT 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 OF N251 (VALVE/CASSETTE TEST FAILURE). THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287950 PLM A+PMP W/SE MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SN (B)(4)| PLUM A+ SOFTWARE MODULE, LIST #12097,