BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM THERAPY S

    MDR report key: 4180549 · Received October 15, 2014

    Report

    Report Number
    9615050-2014-05632
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AT THE SERVICE CENTER THE DEVICE WOULD NOT POWER ON WITH BATTERY POWER AND CORROSION WAS NOTED INSIDE THE BATTERY COMPARTMENT AND THE NEGATIVE BATTERY CONTACT ON THE MIDDLE PRINTED CIRCUIT BOARD OF THE DEVICE. THIS WAS FOUND TO BE DUE TO LEAKAGE FROM THE DISPOSABLE BATTERIES. 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 DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A CUSTOMER REPORT THAT THE DEVICE WILL NOT TURN ON BATTERY POWER. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, BATTERY LEAKAGE WAS FOUND IN THE BATTERY COMPARTMENT AND ON THE NEGATIVE BATTERY CONTACT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654498 GEMSTAR PM THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA