BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR RECHARGEABLE BATTERY PACK

    MDR report key: 1061803 · Received June 13, 2008

    Report

    Report Number
    2921482-2008-00190
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 20, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K000821
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    REPORT RECEIVED OF CHARRING AND MELTING. THE CUSTOMER CONTACT REPORTED THAT THE DEVICE WAS CONNECTED TO A GEMSTAR PUMP WHICH WAS CONNECTED TO A PATIENT. AFTER AN UNSPECIFIED TIME IN USE, THE BATTERY POWER RAN LOW. THE BATTERY PACK WAS THEN CONNECTED TO THE AC POWER SUPPLY. IT WAS REPORTED THAT AT THIS TIME, MELTING AND CHARRING OF THE EXTERNAL SURFACE OF THE BATTERY PACK WAS NOTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR RECHARGEABLE BATTERY PACK 80-FRN FRN HOSPIRA, INC. NA 50991G1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMSTAR 7 THERAPY PUMP