BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER (NEW)

    MDR report key: 3832601 · Received March 17, 2014

    Report

    Report Number
    9615050-2014-01994
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 21, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    Z-0207-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE DISTAL PRESSURE SENSOR HAD DRIFTED OUT OF CALIBRATION. 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

    DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DISTAL PRESSURE SENSOR CALIBRATION HAD DRIFTED OUT OF TOLERANCE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO TRACKING INFORMATION WAS PROVIDED THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING OR, EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156978 PLUM A+ DRIVER (NEW) 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE: LIST #20791,| LIST #20791, (B)(4)