BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ ITALIAN DEVIC

    MDR report key: 3962855 · Received June 13, 2014

    Report

    Report Number
    9615050-2014-04018
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 17, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    FA212-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS FOUND THAT THE DEVICE DISTAL PRESSURE SENSOR PIN WAS BROKEN. THIS REPORT REPRESENTS ALL 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 DEVICE HAD A CONTINUOUS ALARM WITH AN UNSPECIFIED MALFUNCTION CODE. THIS DOES NOT INDICATED 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
    351314 PLM A+ ITALIAN DEVIC 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,