BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA3 MEDNET WIRELESS

    MDR report key: 1931805 · Received November 22, 2010

    Report

    Report Number
    2921482-2010-00921
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DISPLAYED E626 (AUDIBLE ALARM) WITHOUT SOUNDING AN AUDIBLE ALARM TONE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPT WITH AN UNSIGNED NOTE THAT STATED, "NO ALARM, E626 DISPLAYED ON SCREEN." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO INCLUDING EVENT DETAILS AND EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA3 MEDNET WIRELESS 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK