BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 3832683 · Received March 26, 2014

    Report

    Report Number
    9615050-2014-02277
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    January 23, 2014
    Report Date
    February 6, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AT THE SERVICE CENTER, THE DEVICE WOULD NOT POWER ON DC POWER; HOWEVER, WAS ABLE TO BE POWERED ON USING AC POWER. DURING FURTHER TESTING CORROSION DUE TO LEAKAGE FROM THE DISPOSABLE BATTERIES WAS NOTED ON THE BATTERY CONTACT, BATTERY DOOR, BATTERY COMPARTMENT, AND PRINTED CIRCUIT BOARD. THIS 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 CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING, THE DEVICE WOULD NOT TURN ON WITH DC POWER; HOWEVER, IT WOULD POWER ON USING THE POWER CORD. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. 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
    176517 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA