BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3894486 · Received April 25, 2014

    Report

    Report Number
    9615050-2014-02980
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 19, 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 THE DEVICE WOULD NOT POWER UP ON AC OR DC POWER. FURTHER TESTING FOUND LEAKAGE FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT AND THE MIDDLE PRINTED CIRCUIT BOARD OF THE DEVICE. THE PROBABLY CAUSE OF NO AC OR DC POWER WAS THE CORROSION FROM THE BATTERY LEAKAGE ON THE MIDDLE PRINTED CIRCUIT BOARD. 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 CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT DURING ROUTINE TESTING AT THE USER FACILITY, THE DEVICE HAS " NO AC POWER". NO ADDITIONAL INFO WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER LEAKAGE WAS NOTED FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252705 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA