BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ PLATINUM

    MDR report key: 3915197 · Received May 16, 2014

    Report

    Report Number
    9615050-2014-03475
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 21, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS NOTED THAT THE DEVICE DISTAL PRESSURE SENSOR PIN WAS BROKEN. THE CUSTOMER CONTACT'S COMPLAINT OF AN E437 (S/W FAILURE) ERROR CODE COULD NOT BE 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 FOR A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE ALARMED WITH AN E437 (S/W FAILURE) ERROR CODE. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE DISTAL PRESSURE SENSOR PIN WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293527 PLM A+ PLATINUM UNK FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIST #12097, SN UNK| PLUM A+ SOFTWARE MODULE,