BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 3894343 · Received April 23, 2014

    Report

    Report Number
    9615050-2014-02910
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 11, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING LEAKAGE FORM THE DISPOSABLE BATTERIES WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE. THE CUSTOMER REPORTED CHECK CASSETTE ALARM WAS NOT DUPLICATED; HOWEVER, WAS NOTED IN THE DEVICE HISTORY. THIS WAS DUE TO A BROKEN CASSETTE LATCH. 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 DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT DURING ROUTINE TESTING, THE DEVICE ALARMED WITH A CHECK CASSETTE ALARM. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER LEAKAGE FORM THE DISPOSABLE BATTERIES WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245871 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA