BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4213094 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01144
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    December 16, 2011
    Report Date
    December 17, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE COMPANY REP PERFORMED FUNCTIONAL AND LEAKAGE TESTS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. ON A LATER DATE, THE COMPANY REP VISITED THE FACILITY AND PRINTED OUT THE BATTERY STATS. BASED ON THE EVAL, IT WAS SPECULATED THAT THE BATTERIES WERE NOT FULLY CHARGED ON THE DAY OF EVENT. THE COMPANY REP SIMULATED THE EVENT ON THE SAME PUMP. THE POWER MAINS SWITCH WAS TURNED OFF AT 12:15 PM AND THE IABP WAS EVALUATED. THE COMPANY REP OBSERVED THE LOW BATTERY AUDIO ALARM SOUNDED, BATTERY LOW APPEARED ON THE SCREEN AND THE BATTERY SYMBOL STARTED FLASHING EVENTUALLY THE PUMP SHUT DOWN AT 3:00 PM. SINCE THE UNIT WAS OPERABLE FOR 2 HOURS AND 15 MINUTES ON BATTERIES, INDICATING THAT THE BATTERIES MEET THE REQUIRED SPECS AND ARE NOT THE CAUSE FOR THE SHUTDOWN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT SHUT DOWN. THE CUSTOMER BIOMED STATED THAT HE FOUND THE POWER MAINS SWITCH OFF. THE IABP WAS REPLACED AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455541 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1