BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY FR

    MDR report key: 4113812 · Received September 17, 2014

    Report

    Report Number
    9615050-2014-05259
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 18, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    Z-1170-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, CORROSION WAS NOTED IN THE BATTERY COMPARTMENT, ON THE CASE, ON THE BATTERY DOOR, AND ON THE MIDDLE PRINTED CIRCUIT BOARD OF THE DEVICE. THE CAUSE OF THE CORROSION WAS LEAKAGE FROM THE DISPOSABLE AA BATTERIES. 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 CTR WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE WILL ON OPERATE ON DC POWER. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR CORROSION FROM DISPOSABLE AA BATTERY LEAKAGE WAS NOTED ON THE BATTERY COMPARTMENT, ON THE CASE, ON THE BATTERY DOOR, AND MIDDLE PRINTED CIRCUIT BOARD OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575658 GEMSTAR 7 THERAPY FR 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA