BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE 2.25

    MDR report key: 4113828 · Received September 17, 2014

    Report

    Report Number
    9615050-2014-05275
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    August 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K011096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CTR WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE WOULD NOT CHARGE OR TURN ON USING BATTERY. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION; HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR IT WAS NOTED THAT THE BATTERY WAS SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575801 ACCLAIM ENCORE 2.25 80FRN FRN HOSPIRA COSTA RICA LTD. MA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA