BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THPY ALT ST

    MDR report key: 4260747 · Received September 4, 2014

    Report

    Report Number
    9615050-2014-05120
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    Z-1169-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND LEAKAGE FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT. AS INDICATED, THIS 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

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A CUSTOMER CONTACT REPORT THAT DURING POWER UP THE PUMP ALARMED FOR ERROR CODE 11/004. THIS DOES NOT INDICATE A REPORTABLE EVENT. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, LEAKAGE FROM THE DISPOSABLE BATTERIES WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540899 GEMSTAR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA