BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM PMP

    MDR report key: 3894430 · Received April 25, 2014

    Report

    Report Number
    9615050-2014-03008
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    February 15, 2014
    Report Date
    March 6, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    Z-1170-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, LEAKAGE WAS NOTED FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT, TOP AND MIDDLE PRINTED CIRCUIT BOARD AND BATTERY CAP OF THE DEVICE. THE CUSTOMER REPORTED 10/000/000 WAS DUPLICATED DURING TESTING. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A 18/000 (HISTORY POINTER ERROR WHILE INSERTING A NEW RECORD INTO HISTORY LOG) MALFUNCTION ALARM CODE. NO ADDITIONAL INFO WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, BATTERY LEAKAGE WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252153 GEMSTAR PM PMP 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA