BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 4180548 · Received October 15, 2014

    Report

    Report Number
    9615050-2014-05631
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 26, 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 AT THE SERVICE CENTER THE DEVICE WOULD NOT POWER ON. CORROSION WAS NOTED IN THE BATTERY COMPARTMENT, BATTERY DOOR AND MIDDLE PRINTED CIRCUIT BOARD OF THE DEVICE. THE PROBABLE CAUSE OF THE CORROSION WAS DUE TO LEAKAGE FROM THE DISPOSABLE BATTERIES. THE PROBABLE CAUSE OF THE DEVICE NOT POWERING UP WAS DUE TO THE CORROSION ON THE MIDDLE PWA WHICH WAS CAUSED BY THE BATTERY LEAKAGE. 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 CORROSION IN THE BATTERY COMPARTMENT OF THE DEVICE. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, LEAKAGE FROM THE DISPOSABLE BATTERIES WERE NOTED IN THE BATTERY COMPARTMENT, BATTERY DOOR AND MIDDLE PRINTED CIRCUIT BOARD OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655668 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA