BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 3832186 · Received March 7, 2014

    Report

    Report Number
    9615050-2014-01760
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AT THE SERVICE CTR, THE DEVICE ALARMED WITH AN 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE CODE ALARM CODE. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DEVICE ALARMED WITH AN 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE CODE ALARM. THE DEVICE WAS RETURNED TO THE BIOMED DEPT FROM AN UNK CLINICAL AREA. THE CUSTOMER CONTACT INDICATED THE DEVICE HAD AN AUDIBLE ALARM WITH THE 11/004 SERVICE ALARM CODE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138499 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK