BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3874756 · Received April 25, 2014

    Report

    Report Number
    2249723-2014-00524
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAQUET REPRESENTATIVE REPLACED BOTH BATTERIES (PART NUMBER 0146-00-0097) POWER MANAGEMENT BOARD (PART NUMBER 0670-00-00767) AND POWER SLOT INTERFACE (PART NUMBER 0670-00-0842) ON THE CARDIOSAVE. THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE LI-ION BATTERIES (PART NUMBER 0146-00-0097) WERE SENT TO (B)(4) FOR REPAIR WHERE THE BATTERIES WERE EXTENSIVELY TESTED AND EVALUATED. HOWEVER, THE PROBLEM COULD NOT BE DUPLICATED. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK OF THE IABP, THE COMPANY REPRESENTATIVE OBSERVED THAT THE BATTERIES WERE LEFT DEPLETED FOR TOO LONG, RESULTING IN BOTH BATTERIES NOT BEING ABLE TO BE RE-CHARGED. BOTH OF THE DEPLETED BATTERIES CONNECTED TO THE IABP, WHEN RUNNING FROM THE MAINS SUPPLY, WOULD SHOUT DOWN WITHOUT WARNING AFTER ONE OR TWO MINUTES, CAUSING THE SHUT DOWN ALARM TO SOUND WITH NO LOW BATTERY WARNING. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250484 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE

    Patients

    Seq Age Sex Outcome Treatment
    1