BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 3802813 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01432
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 23, 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 FOUND AT POWER UP THE DEVICE ALARMED FOR 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE CODE ALARM. 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

    THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH A 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE ALARM CODE. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FROM AN UNKNOWN FLOOR WITH NO NOT ATTACHED. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OR ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY AFTER THE DEVICE WAS POWERED ON, THE DEVICE ALARMED WITH A 11/004 WAS POWERED ON, THE DEVICE ALARMED WITH A 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108935 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK