BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM THERAPY S

    MDR report key: 4102377 · Received August 27, 2014

    Report

    Report Number
    9615050-2014-04985
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 8, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    Z1170-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND CORROSION ON THE BATTERY COVER AND THE BATTERY COMPARTMENT OF THE DEVICE. THE CAUSE OF THE CORROSION WAS LEAKAGE FROM THE DISPOSABLE AA BATTERIES. AS INDICATED, 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 CORROSION ON THE BATTERY OF THE DEVICE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, CORROSION WAS NOTED ON THE BATTERY OF THE DEVICE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522560 GEMSTAR PM THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA