BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3031015 · Received March 28, 2013

    Report

    Report Number
    2249723-2013-00031
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EVALUATED THE IABP. HE CONFIRMED THAT AN ODOR WAS COMING FROM THE POWER SUPPLY VENT. WE ARE IN THE PROCESS OF MAKING ARRANGEMENTS FOR THE POWER SUPPLY TO BE RETURNED TO THE FACTORY FOR FURTHER EVALUATION. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS PLUGGED INTO A WALL OUTLET IN THE CATH LAB, NOT IN USE, SMOKE AND AN UNPLEASANT ODOR CAME FROM THE IABP. THE OPERATING ROOM WAS EVACUATED. THREE MEMBERS OF THE HOSPITAL STAFF REPORTED A BURNING SENSATION AROUND THE THROAT AND EYES. NO MEDICAL TREATMENT WAS SOUGHT. A CATHETERIZATION PROCEDURE BEING PERFORMED IN THE NEXT ROOM WAS STOPPED. NO PATIENT INJURY WAS REPORTED. THE FIRE DEPARTMENT WAS CALLED, AND THEY DID NOT FIND ANYTHING IN THE ROOM THAT WOULD HAVE CAUSED THE SMOKE. THE CUSTOMER'S BIOMED EVALUATED THE IABP. THEY REPORTED THAT WHEN MACHINE WAS TURNED ON, THE POWER SUPPLY FAN ON THE IABP BLEW THE SAME SMELL AS THAT IN THE ROOM AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128690 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other