BEUDAMED
    FDA Adverse Event Summary report: N

    INTRA-AORTIC BALLOON PUMP

    MDR report key: 2192017 · Received July 29, 2011

    Report

    Report Number
    2249723-2011-00148
    Date Received
    July 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PUMP IS MAINTAINED BY THE CUSTOMER'S BIOMED. DATASCOPE HAS ATTEMPTED TO CONTACT THE BIOMED WHO REPORTED THE EVENT FOUR TIMES, BY EMAIL AND BY PHONE, TO OBTAIN ADD'L DETAILS OF THE EVENT, INCLUDING: SERIAL NUMBER AND STATUS OF THE PUMP, AND PT OUTCOME. WE HAVE NOT RECEIVED A RESPONSE; THEREFORE, WE HAVE NO ADD'L INFO TO PROVIDE AT THIS TIME. IF ANY ADD'L INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SENT TO FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT DURING TRANSPORT, THE UNIT SHUTDOWN. HE ADVISED THAT THE SHUTDOWN WAS THE RESULT OF SWOLLEN BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK