BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 1950149 · Received December 9, 2010

    Report

    Report Number
    2921482-2010-00973
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 25, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, THE DEVICE DISPLAYED E175 (WATCHDOG ERROR) AND E626 (AUDIBLE ALARM) WITHOUT SOUNDING AN AUDIBLE ALARM TONE. THIS WAS DUE TO SPILLAGE AND CORROSION THROUGHOUT THE MICRO CONTROLLER UNIT PRINTED CIRCUIT BOARD. THE SPILLAGE AND CORROSION ARE DUE TO USE OF THE DEVICE IN THE CUSTOMER ENVIRONMENT. EVENT PROBLEM: THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(6).

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE MFG FACILITY, THE DEVICE DISPLAYED E175 (WATCHDOG ERROR) AND E626 (AUDIBLE ALARM) WITHOUT SOUNDING AN AUDIBLE ALARM TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA