BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 4113844 · Received September 17, 2014

    Report

    Report Number
    9615050-2014-05273
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    August 26, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TESTING WAS DONE AT USER FACILITY. THE DEVICE AC POWER CORD IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT BEEN RECEIVED. THIS REPORT REPRESENTS ALL INFO 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 AC POWER CORD PRONGS WERE BENT. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT WITH AN UNSIGNED NOT THAT INDICATED "BROKEN." NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. 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
    575839 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK