BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM THERAPY S

    MDR report key: 3832209 · Received March 7, 2014

    Report

    Report Number
    9615050-2014-01795
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 6, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND LEAKAGE FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT OF THE DEVICE. 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 BATTERY LEAKAGE WAS NOTED INSIDE THE DEVICE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FROM AN UNKNOWN FLOOR FOR AN UNSPECIFIED REASON. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTIN THE CUSTOMER CONTACT REPORTED THE DEVICE WAS OPERABLE ON AC AND DC POWER. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138772 GEMSTAR PM THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK