BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE XL

    MDR report key: 4180555 · Received October 15, 2014

    Report

    Report Number
    9615050-2014-05641
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    FA311-04
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE TO HAVE A BROKEN DOOR HANDLE AND A BROKEN DOOR ROLLER PIN. THE PROBABLE CAUSE FOR THE BROKEN DEVICE DOOR ROLLER AND PIN WAS LEAVING THE DEVICE DOOR ASSEMBLY IN THE OPEN POSITION EXPOSING THE DEVICE DOOR ROLLER TO CONTACT DAMAGE. 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 CUSTOMER CONTACT REPORTED THAT THE DEVICE DOOR ROLLER, DOOR ROLLER PIN, AND HANDLE DOOR WERE BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654508 LIFECARE XL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA