BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3964185 · Received May 28, 2014

    Report

    Report Number
    9615050-2014-03685
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    Z-1159-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION AT THE SERVICE CENTER FOUND THE DEVICE ALARMED FOR ERROR CODE 18/000/000 (HISTORY POINTER ERROR WHILE INSERTING A NEW RECORD INTO HISTORY LOG) AND 11/004/013 (LESS THAN 2.0 VOLTS MEASURED ON LITHIUM BATTERY) ON START UP. THE PROBABLE CAUSE OF BOTH ALARM CODES WAS A DEPLETED LITHIUM BATTERY. 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 CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH THE SERVICE CODE 11/004/024 (LESS THAN 2.0 VOLTS MEASURED ON LITHIUM BATTERY). 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
    314940 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA