BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3874789 · Received April 25, 2014

    Report

    Report Number
    2249723-2014-00541
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    September 24, 2013
    Report Date
    September 25, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) REP REPLACED THE EXTERNAL OUTPUT CABLE ASSEMBLY (PART NUMBER 0012-0-0886-01) ON (B)(6) 2013. AFTER THE REPLACEMENT, THE CALIBRATION WAS PERFORMED. THE FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECIFICATIONS AND THE DEVICE IS A FULLY OPERATIONAL. THE DEFECTIVE CABLE WAS FORWARD TO (B)(4) FOR EVALUATION. A FAILURE ANALYSIS WAS PERFORMED BY THE SUPPLIER (ELECTRI-CORD) ON THE 'BURNT PLUG' THAT OCCURRED ON AN 110V AC LINE CORD (PART NUMBER 0012-00-0886-01). THE SUPPLIER DETERMINED THAT THE FAILURE WAS CAUSED BY A SHORT AND APPEARS TO HAVE BEEN SUBJECTED TO 'ABUSIVE' USE. THIS IS A SECOND OCCURRENCE OF THE 'BURNT' LINE CORD FAILURE SYMPTOM OF THIS PART. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT, THE CUSTOMER OBSERVED BURN MARKS ON THE PLUG OF THE POWER SUPPLY CABLE AND THE POWER STRIP. THE CUSTOMER DECIDED NOT TO USE THE IABP FOR THE PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250456 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1