BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3050629 · Received March 13, 2013

    Report

    Report Number
    9615050-2013-00371
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 4, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THIS WAS DUE TO CORROSION ON THE MIDDLE PRINTED CIRCUIT BOARD. THE CAUSE OF THE CORROSION WAS SPILLAGE FROM USE IN THE CUSTOMER ENVIRONMENT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SVC CENTER, THE DEVICE DID NOT SOUND AN ALARM TONE DURING AN ALARM CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106606 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA