BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ SPANISH DEVIC

    MDR report key: 3952746 · Received May 19, 2014

    Report

    Report Number
    9615050-2014-03493
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    FA210-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AT THE USER FACILITY, DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. ADDITIONALLY DURING TESTING, TI WAS NOTED THAT HE BATTERY WAS SWOLLEN. LEAD ACID BATTERY OPERATION IS BASED ON AN ELECTROCHEMICAL REACTION WHICH IS AFFECTED BY TEMPERATURE CHANGES AND AGING EFFECTS OF THE BATTERY. THIS REDUCES THE DISCHARGE CAPACITY OF THE BATTERY AND MAY INCREASE THE INTERNAL TEMPERATURE DURING THE CHARGING AND DISCHARGING PROCESS WHICH COULD RESULT IN SWELLING OF THE BATTERY. FOR HIGH INTERNAL BATTERY TEMPERATURES THE EFFECTS MAY RESULT IN DETERIORATION OF SERVICE LIFE. 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

    DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE, AND IT WAS NOTED THAT THE BATTERY WAS SWOLLEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO 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
    296268 PLM A+ SPANISH DEVIC 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE: LIST #12097, SN UNK