BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ INTERNATIONA

    MDR report key: 3964068 · Received May 5, 2014

    Report

    Report Number
    9615050-2014-03203
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 3, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    Z-0207-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS NOTED THAT THE DISTAL PRESSURE SENSOR CALIBRATION HAD DRIFTED OUT OF TOLERANCE. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 WITH A REPORT FROM THE CUSTOMER CONTACT THAT STATED, "DISTAL PRESSURE ZERO OFFSET IS OUT OF RANGE (-93.7 MMHG)". HOWEVER, DURING TESTING AT THE SERVICE CENTER, THE DISTAL PRESSURE SENSOR CALIBRATION HAD DRIFTER OUT OF TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268331 PLUM A+ INTERNATIONA 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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