BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ MEDNET FMW

    MDR report key: 4684156 · Received April 9, 2015

    Report

    Report Number
    9615050-2015-00922
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 31, 2015
    Report Date
    March 31, 2015
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. 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 BATTERY WAS SWOLLEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPT FOR A REPORT OF BATTERY WILL NOT HOLD A CHARGE. NO TRACKING 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
    233477 PLM A+ MEDNET FMW FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1