BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 98

    MDR report key: 4102581 · Received August 27, 2014

    Report

    Report Number
    2249723-2014-01227
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    January 4, 2012
    Report Date
    January 6, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET (B)(6) EVALUATED THE IABP ERROR LOGS AND RECOMMENDED REPLACING THE FRONT END BOARD TO THE HOSPITAL. THE HOSPITAL DIDN'T ACCEPT THE REPLACEMENT PART AND USED A LOANER PUMP. THEY ARE CONSIDERING BUYING A NEW UNIT INSTEAD. REF.: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT GENERATED A "SYSTEM FAILURE" ALARM WITH A FAULT INDEX 53 (FRONT END FAULT). THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519102 SYSTEM 98 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. SYSTEM 98

    Patients

    Seq Age Sex Outcome Treatment
    1