BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3554580 · Received November 27, 2013

    Report

    Report Number
    2249723-2013-00163
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 7, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED A SLIGHT ODOR FROM THE POWER SUPPLY EXHAUST FAN AND VERIFIED THAT ALL PC BOARDS WERE NOT DAMAGED. AS A PRECAUTIONARY MEASURE, HE REPLACED THE POWER SUPPLY (PART NUMBER 0014-00-0033E05). IN AN UNRELATED REPAIR, THE AC LINE CORD CABLE (PART NUMBER 0012-00-0886-01) WAS ALSO REPLACED BECAUSE IT WAS FRAYED. THE IABP WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT, HE NOTED A FOUL ODOR COMING FROM THE POWER SUPPLY EXHAUST OF THE IABP. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620052 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU